RECRUITING

Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

Conditions

Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 HER2-Negative Breast Carcinoma Hormone Receptor-Positive Breast Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.

Official Title

Phase III Trial Of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone For Adults With MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

Quick Facts

Study Start:2023-11-27

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06058377

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* STEP 1: REGISTRATION (SCREENING): Participants must have histologically confirmed estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer, as per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines * NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible * STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer * NOTE: Participants with inflammatory breast cancer are eligible * NOTE: Participants with occult (i.e. undetectable) primary breast cancer with axillary nodal involvement are not eligible, as MammaPrint testing has not been validated on tissue obtained from an axillary lymph node * STEP 1: REGISTRATION (SCREENING): Participants must not have metastatic disease (i.e., must be clinically M0 or Mx) Systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network (NCCN) and ASCO guidelines * STEP 1: REGISTRATION (SCREENING): Participants must not have locally recurrent breast cancer * STEP 1: REGISTRATION (SCREENING): Participants with multifocal disease in the same breast or synchronous bilateral primary tumors are eligible, however, all tumors that are biopsied must be hormone receptor positive and HER2 negative per ASCO CAP guidelines and at least one of the tumors must be MammaPrint High-2. MammaPrint can be performed sequentially on biopsies as it is sufficient to have MammaPrint High 2 status on at least one of the lesions * NOTE: Biopsy of multiple lesions in the same breast is not required if the clinical presentation is consistent with a single disease process that is multifocal in nature. However, if there is clinical suspicion of two distinct primary breast malignancies, additional biopsies should be pursued * STEP 1: REGISTRATION (SCREENING): Participants must have either adequate tissue available to submit on-study or a prior known MammaPrint Index Score that is MP2 status * Submitting tissue for on-study MammaPrint testing: * Participants must have a minimum of ten, unstained formalin-fixed paraffin-embedded (FFPE) slides (4-5 micron thickness) available from initial tumor biopsy for MammaPrint assessment * NOTE: Participants must agree to have this tissue submitted to Agendia for MammaPrint Index Scoring and to have subsequent results disclosed to Southwest Oncology Group (SWOG) Cancer Research Network OR * Submitting prior known MammaPrint Index Score: * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy * NOTE: Participants must agree to have their commercial MammaPrint Index Score disclosed to SWOG Cancer Research Network * NOTE: Participants with prior known MammaPrint result that is not MP2 status should not be enrolled to either step of this study * NOTE: Participants enrolling with known MP2 status (i.e. MP already obtained as routine care) must only sign the treatment informed consent form. Screening consent is not required when MP2 status is known prior to study enrollment * STEP 1: REGISTRATION (SCREENING): Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy * STEP 1: REGISTRATION (SCREENING): Participants must be \>= 18 years old at the time of registration * STEP 1: REGISTRATION (SCREENING): Participants must have body weight \> 30 kg * STEP 1: REGISTRATION (SCREENING): Participants must have Zubrod Performance Status of 0-2 * STEP 1: REGISTRATION (SCREENING): Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * STEP 1: REGISTRATION (SCREENING): Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed * STEP 1: REGISTRATION (SCREENING): NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations * STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for Step 1 Registration * STEP 2: RANDOMIZATION: Participants must have MammaPrint High Risk 2 result * For participants submitting tissue for on-study MammaPrint testing: * Participants must be registered to Step 2: Randomization within 84 calendar days (12 weeks) after receiving an MP2 status from the MammaPrint Index score. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) from initial tumor biopsy OR * Submitting commercial MammaPrint Index Score: * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy * NOTE: Participants without a MammaPrint High-Risk 2 score must not be registered to Step 2 Randomization * STEP 2: RANDOMIZATION: Participants must not have received live vaccines within 28 days prior to study Step 2: Randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines and coronavirus disease 2019 (COVID-19) vaccines are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed * STEP 2: RANDOMIZATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study * STEP 2: RANDOMIZATION: Participant must have Zubrod Performance Status of 0-2 * STEP 2: RANDOMIZATION: Participants must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis within two years prior to Step 2: Randomization * STEP 2: RANDOMIZATION: Participants must not have active autoimmune disease that has required systemic treatment in the past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) prior to Step 2: Randomization. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed * STEP 2: RANDOMIZATION: Participant must have a complete medical history and physical exam within 28 days prior to Step 2: Randomization * STEP 2: RANDOMIZATION: Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to Step 2: Randomization) * STEP 2: RANDOMIZATION: Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to Step 2: Randomization) * STEP 2: RANDOMIZATION: Platelets \>= 100 x 10\^3/uL (within 28 days prior to Step 2: Randomization) * STEP 2: RANDOMIZATION: Total bilirubin =\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to Step 2: Randomization) * STEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 × institutional ULN (within 28 days prior to Step 2: Randomization) * STEP 2: RANDOMIZATION: Participants must have a calculated creatinine clearance \>= 50 mL/min using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 2: Randomization * STEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better * STEP 2: RANDOMIZATION: Participants must not have uncontrolled diabetes defined as hemoglobin A1c of 9.0% or greater, within 28 days prior to Step 2: Randomization * STEP 2: RANDOMIZATION: Participants with history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have an undetectable viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization * STEP 2: RANDOMIZATION: Participants with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained while on suppressive therapy within 6 months prior to Step 2: Randomization, if indicated * STEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization, if indicated * STEP 2: RANDOMIZATION: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process and must have a negative pregnancy test at screening. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy * STEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System * STEP 2: RANDOMIZATION: Participants who can complete questionnaires in English, or Spanish must be offered the opportunity to participate in the Quality of Life study * STEP 2: RANDOMIZATION: NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * STEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* STEP 1: REGISTRATION (SCREENING): Participants must have histologically confirmed estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer, as per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines
* NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible
* STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer
* NOTE: Participants with inflammatory breast cancer are eligible
* NOTE: Participants with occult (i.e. undetectable) primary breast cancer with axillary nodal involvement are not eligible, as MammaPrint testing has not been validated on tissue obtained from an axillary lymph node
* STEP 1: REGISTRATION (SCREENING): Participants must not have metastatic disease (i.e., must be clinically M0 or Mx) Systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network (NCCN) and ASCO guidelines
* STEP 1: REGISTRATION (SCREENING): Participants must not have locally recurrent breast cancer
* STEP 1: REGISTRATION (SCREENING): Participants with multifocal disease in the same breast or synchronous bilateral primary tumors are eligible, however, all tumors that are biopsied must be hormone receptor positive and HER2 negative per ASCO CAP guidelines and at least one of the tumors must be MammaPrint High-2. MammaPrint can be performed sequentially on biopsies as it is sufficient to have MammaPrint High 2 status on at least one of the lesions
* NOTE: Biopsy of multiple lesions in the same breast is not required if the clinical presentation is consistent with a single disease process that is multifocal in nature. However, if there is clinical suspicion of two distinct primary breast malignancies, additional biopsies should be pursued
* STEP 1: REGISTRATION (SCREENING): Participants must have either adequate tissue available to submit on-study or a prior known MammaPrint Index Score that is MP2 status
* Submitting tissue for on-study MammaPrint testing:
* Participants must have a minimum of ten, unstained formalin-fixed paraffin-embedded (FFPE) slides (4-5 micron thickness) available from initial tumor biopsy for MammaPrint assessment
* NOTE: Participants must agree to have this tissue submitted to Agendia for MammaPrint Index Scoring and to have subsequent results disclosed to Southwest Oncology Group (SWOG) Cancer Research Network OR
* Submitting prior known MammaPrint Index Score:
* If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy
* NOTE: Participants must agree to have their commercial MammaPrint Index Score disclosed to SWOG Cancer Research Network
* NOTE: Participants with prior known MammaPrint result that is not MP2 status should not be enrolled to either step of this study
* NOTE: Participants enrolling with known MP2 status (i.e. MP already obtained as routine care) must only sign the treatment informed consent form. Screening consent is not required when MP2 status is known prior to study enrollment
* STEP 1: REGISTRATION (SCREENING): Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy
* STEP 1: REGISTRATION (SCREENING): Participants must be \>= 18 years old at the time of registration
* STEP 1: REGISTRATION (SCREENING): Participants must have body weight \> 30 kg
* STEP 1: REGISTRATION (SCREENING): Participants must have Zubrod Performance Status of 0-2
* STEP 1: REGISTRATION (SCREENING): Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* STEP 1: REGISTRATION (SCREENING): Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed
* STEP 1: REGISTRATION (SCREENING): NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
* STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for Step 1 Registration
* STEP 2: RANDOMIZATION: Participants must have MammaPrint High Risk 2 result
* For participants submitting tissue for on-study MammaPrint testing:
* Participants must be registered to Step 2: Randomization within 84 calendar days (12 weeks) after receiving an MP2 status from the MammaPrint Index score. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) from initial tumor biopsy OR
* Submitting commercial MammaPrint Index Score:
* If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy
* NOTE: Participants without a MammaPrint High-Risk 2 score must not be registered to Step 2 Randomization
* STEP 2: RANDOMIZATION: Participants must not have received live vaccines within 28 days prior to study Step 2: Randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines and coronavirus disease 2019 (COVID-19) vaccines are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed
* STEP 2: RANDOMIZATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
* STEP 2: RANDOMIZATION: Participant must have Zubrod Performance Status of 0-2
* STEP 2: RANDOMIZATION: Participants must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis within two years prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants must not have active autoimmune disease that has required systemic treatment in the past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) prior to Step 2: Randomization. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed
* STEP 2: RANDOMIZATION: Participant must have a complete medical history and physical exam within 28 days prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Platelets \>= 100 x 10\^3/uL (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Total bilirubin =\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 × institutional ULN (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Participants must have a calculated creatinine clearance \>= 50 mL/min using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
* STEP 2: RANDOMIZATION: Participants must not have uncontrolled diabetes defined as hemoglobin A1c of 9.0% or greater, within 28 days prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants with history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have an undetectable viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained while on suppressive therapy within 6 months prior to Step 2: Randomization, if indicated
* STEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization, if indicated
* STEP 2: RANDOMIZATION: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process and must have a negative pregnancy test at screening. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy
* STEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System
* STEP 2: RANDOMIZATION: Participants who can complete questionnaires in English, or Spanish must be offered the opportunity to participate in the Quality of Life study
* STEP 2: RANDOMIZATION: NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* STEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Erin F Cobain

PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Study Locations (Sites)

Banner University Medical Center - Tucson

Tucson, Arizona, 85719

United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719

United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903

United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401

United States

Sutter Auburn Faith Hospital

Auburn, California, 95602

United States

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, 93301

United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704

United States

Tower Cancer Research Foundation

Beverly Hills, California, 90211

United States

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

United States

Palo Alto Medical Foundation-Fremont

Fremont, California, 94538

United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612

United States

City of Hope at Irvine Lennar

Irvine, California, 92618

United States

City of Hope Antelope Valley

Lancaster, California, 93534

United States

Loma Linda University Medical Center

Loma Linda, California, 92354

United States

City of Hope at Long Beach Elm

Long Beach, California, 90813

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Memorial Medical Center

Modesto, California, 95355

United States

City of Hope Newport Beach

Newport Beach, California, 92660

United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868

United States

Desert Regional Medical Center

Palm Springs, California, 92262

United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301

United States

Huntington Memorial Hospital

Pasadena, California, 91105

United States

Sutter Roseville Medical Center

Roseville, California, 95661

United States

Sutter Medical Center Sacramento

Sacramento, California, 95816

United States

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110

United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115

United States

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, 95065

United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, 95403

United States

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403

United States

Providence Santa Rosa Memorial Hospital

Santa Rosa, California, 95405

United States

City of Hope South Pasadena

South Pasadena, California, 91030

United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086

United States

Cedars-Sinai Cancer - Tarzana

Tarzana, California, 91356

United States

City of Hope South Bay

Torrance, California, 90503

United States

Torrance Memorial Physician Network - Cancer Care

Torrance, California, 90505

United States

City of Hope Upland

Upland, California, 91786

United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589

United States

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045

United States

UCHealth - Cherry Creek

Denver, Colorado, 80206

United States

Shaw Cancer Center

Edwards, Colorado, 81632

United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129

United States

UCHealth Lone Tree Health Center

Lone Tree, Colorado, 80124

United States

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418

United States

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824

United States

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, 06033

United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830

United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437

United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105

United States

Yale University

New Haven, Connecticut, 06520

United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473

United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, 06902

United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790

United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611

United States

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708

United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385

United States

Beebe South Coastal Health Campus

Millville, Delaware, 19967

United States

Helen F Graham Cancer Center

Newark, Delaware, 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713

United States

Beebe Health Campus

Rehoboth Beach, Delaware, 19971

United States

Sibley Memorial Hospital

Washington, District of Columbia, 20016

United States

Morton Plant Hospital

Clearwater, Florida, 33756

United States

Jupiter Medical Center

Jupiter, Florida, 33458

United States

Mount Sinai Medical Center

Miami Beach, Florida, 33140

United States

Mease Countryside Hospital

Safety Harbor, Florida, 34695

United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607

United States

Winter Haven Hospital

Winter Haven, Florida, 33881

United States

Grady Health System

Atlanta, Georgia, 30303

United States

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864

United States

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

Northwestern University

Chicago, Illinois, 60611

United States

University of Illinois

Chicago, Illinois, 60612

United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657

United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

United States

Illinois CancerCare-Dixon

Dixon, Illinois, 61021

United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Advocate Sherman Hospital

Elgin, Illinois, 60123

United States

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026

United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030

United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429

United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

United States

AMG Libertyville - Oncology

Libertyville, Illinois, 60048

United States

Condell Memorial Hospital

Libertyville, Illinois, 60048

United States

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

Trinity Medical Center

Moline, Illinois, 61265

United States

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699

United States

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

Illinois CancerCare-Peru

Peru, Illinois, 61354

United States

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

United States

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, 61114

United States

Memorial Hospital East

Shiloh, Illinois, 62269

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

Illinois CancerCare - Washington

Washington, Illinois, 61571

United States

Northwest Cancer Center - Main Campus

Crown Point, Indiana, 46307

United States

Northwest Oncology LLC

Dyer, Indiana, 46311

United States

Northwest Cancer Center - Hobart

Hobart, Indiana, 46342

United States

Saint Mary Medical Center

Hobart, Indiana, 46342

United States

Saint Catherine Hospital

Indianapolis, Indiana, 46312

United States

The Community Hospital

Munster, Indiana, 46321

United States

Women's Diagnostic Center - Munster

Munster, Indiana, 46321

United States

Northwest Cancer Center - Valparaiso

Valparaiso, Indiana, 46383

United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023

United States

Saint Anthony Regional Hospital

Carroll, Iowa, 51401

United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325

United States

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309

United States

Broadlawns Medical Center

Des Moines, Iowa, 50314

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314

United States

Trinity Regional Medical Center

Fort Dodge, Iowa, 50501

United States

HaysMed

Hays, Kansas, 67601

United States

University of Kansas Cancer Center

Kansas City, Kansas, 66160

United States

Lawrence Memorial Hospital

Lawrence, Kansas, 66044

United States

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, 66061

United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210

United States

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211

United States

Salina Regional Health Center

Salina, Kansas, 67401

United States

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606

United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205

United States

Saint Joseph Hospital East

Lexington, Kentucky, 40509

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

Ochsner LSU Health Monroe Medical Center

Monroe, Louisiana, 71202

United States

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103

United States

Ochsner LSU Health - Cancer Treatment Center

Shreveport, Louisiana, 71106

United States

UM Upper Chesapeake Hematology and Oncology - Aberdeen

Aberdeen, Maryland, 21001

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

Mercy Medical Center

Baltimore, Maryland, 21202

United States

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, 21014

United States

UPMC Western Maryland

Cumberland, Maryland, 21502

United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061

United States

William E Kahlert Regional Cancer Center/Sinai Hospital

Westminster, Maryland, 21157

United States

Beverly Hospital

Beverly, Massachusetts, 01915

United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805

United States

Addison Gilbert Hospital

Gloucester, Massachusetts, 01930

United States

Lahey Medical Center-Peabody

Peabody, Massachusetts, 01960

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, 48116

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Caro Cancer Center

Caro, Michigan, 48723

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038

United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124

United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236

United States

Henry Ford River District Hospital

East China Township, Michigan, 48054

United States

OSF Saint Francis Hospital and Medical Group

Escanaba, Michigan, 49829

United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334

United States

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, 48336

United States

Cancer Hematology Centers - Flint

Flint, Michigan, 48503

United States

Genesee Hematology Oncology PC

Flint, Michigan, 48503

United States

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

United States

Hurley Medical Center

Flint, Michigan, 48503

United States

Henry Ford Saint John Hospital - Van Elslander

Grosse Pointe Woods, Michigan, 48236

United States

Allegiance Health

Jackson, Michigan, 49201

United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910

United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044

United States

Henry Ford Health Providence Novi Hospital

Novi, Michigan, 48374

United States

Henry Ford Medical Center-Columbus

Novi, Michigan, 48377

United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341

United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073

United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601

United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604

United States

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, 48075

United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764

United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085

United States

Henry Ford Health Warren Hospital

Warren, Michigan, 48093

United States

Henry Ford Warren Hospital - GLCMS

Warren, Michigan, 48093

United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322

United States

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661

United States

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401

United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636

United States

Essentia Health Cancer Center

Duluth, Minnesota, 55805

United States

Saint Luke's Hospital of Duluth

Duluth, Minnesota, 55805

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746

United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Hennepin County Medical Center

Minneapolis, Minnesota, 55415

United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Essentia Health Sandstone

Sandstone, Minnesota, 55072

United States

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792

United States

Ridgeview Medical Center

Waconia, Minnesota, 55387

United States

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, 39705

United States

Baptist Cancer Center-Grenada

Grenada, Mississippi, 38901

United States

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, 38652

United States

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, 38655

United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, 65212

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

Parkland Health Center - Farmington

Farmington, Missouri, 63640

United States

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109

United States

University Health Truman Medical Center

Kansas City, Missouri, 64108

United States

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154

United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064

United States

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Mercy Hospital South

Saint Louis, Missouri, 63128

United States

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

United States

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

United States

Siteman Cancer Center at Christian Hospital

Saint Louis, Missouri, 63136

United States

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

CoxHealth South Hospital

Springfield, Missouri, 65807

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

United States

Community Hospital of Anaconda

Anaconda, Montana, 59711

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Community Medical Center

Missoula, Montana, 59804

United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052

United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102

United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148

United States

Renown Regional Medical Center

Reno, Nevada, 89502

United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

United States

Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus

Elizabeth, New Jersey, 07207

United States

The Cancer Institute of New Jersey Hamilton

Hamilton, New Jersey, 08690

United States

Jersey City Medical Center

Jersey City, New Jersey, 07302

United States

Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701

United States

Monmouth Medical Center

Long Branch, New Jersey, 07740

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

Rutgers New Jersey Medical School

Newark, New Jersey, 07101

United States

Newark Beth Israel Medical Center

Newark, New Jersey, 07112

United States

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876

United States

Community Medical Center

Toms River, New Jersey, 08755

United States

NYU Langone Hospital - Brooklyn

Brooklyn, New York, 11220

United States

Glens Falls Hospital

Glens Falls, New York, 12801

United States

NYU Langone Hospital - Long Island

Mineola, New York, 11501

United States

Northern Westchester Hospital

Mount Kisco, New York, 10549

United States

Mount Sinai Chelsea

New York, New York, 10011

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

United States

Mount Sinai West

New York, New York, 10019

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Manhattan Eye Ear and Throat Hospital

New York, New York, 10065

United States

Lenox Hill Hospital

New York, New York, 10075

United States

Upstate Cancer Center at Oswego

Oswego, New York, 13126

United States

Phelps Memorial Hospital Center

Sleepy Hollow, New York, 10591

United States

Staten Island University Hospital

Staten Island, New York, 10305

United States

Stony Brook University Medical Center

Stony Brook, New York, 11794

United States

State University of New York Upstate Medical University

Syracuse, New York, 13210

United States

SUNY Upstate Medical Center-Community Campus

Syracuse, New York, 13215

United States

Upstate Cancer Center at Verona

Verona, New York, 13478

United States

Dickstein Cancer Treatment Center

White Plains, New York, 10601

United States

Rex Hematology Oncology Associates-Cary

Cary, North Carolina, 27518

United States

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328

United States

Rex Hematology Oncology Associates-Garner

Garner, North Carolina, 27529

United States

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534

United States

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546

United States

UNC Rex Healthcare

Raleigh, North Carolina, 27607

United States

UNC Rex Cancer Center of Wakefield

Raleigh, North Carolina, 27614

United States

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, 58103

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

MetroHealth Medical Center

Cleveland, Ohio, 44109

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, 43214

United States

Riverside Methodist Hospital

Columbus, Ohio, 43214

United States

Grant Medical Center

Columbus, Ohio, 43215

United States

Doctors Hospital

Columbus, Ohio, 43228

United States

Miami Valley Hospital

Dayton, Ohio, 45409

United States

Premier Blood and Cancer Center

Dayton, Ohio, 45409

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, 43015

United States

Grady Memorial Hospital

Delaware, Ohio, 43015

United States

Columbus Oncology and Hematology Associates

Dublin, Ohio, 43016

United States

Dublin Methodist Hospital

Dublin, Ohio, 43016

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331

United States

OhioHealth Mansfield Hospital

Mansfield, Ohio, 44903

United States

OhioHealth Marion General Hospital

Marion, Ohio, 43302

United States

OhioHealth Pickerington Methodist Hospital

Pickerington, Ohio, 43147

United States

ProMedica Flower Hospital

Sylvania, Ohio, 43560

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

OhioHealth Westerville Medical Campus/Westerville Cancer Center

Westerville, Ohio, 43082

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120

United States

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, 74146

United States

Saint Charles Health System

Bend, Oregon, 97701

United States

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030

United States

Providence Hood River Memorial Hospital

Hood River, Oregon, 97031

United States

Providence Newberg Medical Center

Newberg, Oregon, 97132

United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

United States

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

SWOG

Portland, Oregon, 97239

United States

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062

United States

Saint Luke's Cancer Center - Allentown

Allentown, Pennsylvania, 18104

United States

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, 15009

United States

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, 18015

United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010

United States

UPMC Hillman Cancer Center at Butler Health System

Butler, Pennsylvania, 16001

United States

UPMC Hillman Cancer Center - Passavant - Cranberry

Cranberry Township, Pennsylvania, 16066

United States

Geisinger Medical Center

Danville, Pennsylvania, 17822

United States

Saint Luke's Hospital-Anderson Campus

Easton, Pennsylvania, 18045

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505

United States

Saint Vincent Hospital

Erie, Pennsylvania, 16544

United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601

United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109

United States

IRMC Cancer Center

Indiana, Pennsylvania, 15701

United States

Jefferson Hospital

Jefferson Hills, Pennsylvania, 15025

United States

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, 15901

United States

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837

United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050

United States

Riddle Memorial Hospital

Media, Pennsylvania, 19063

United States

Forbes Hospital

Monroeville, Pennsylvania, 15146

United States

UPMC Hillman Cancer Center in Coraopolis

Moon, Pennsylvania, 15108

United States

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

United States

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, 15243

United States

Saint Luke's Hospital - Upper Bucks Campus

Quakertown, Pennsylvania, 18951

United States

Community Medical Center

Scranton, Pennsylvania, 18510

United States

Saint Luke's Hospital - Monroe Campus

Stroudsburg, Pennsylvania, 18360

United States

UPMC Cancer Center-Washington

Washington, Pennsylvania, 15301

United States

UPMC West Mifflin-Cancer Center Jefferson

West Mifflin, Pennsylvania, 15122

United States

Wexford Health and Wellness Pavilion

Wexford, Pennsylvania, 15090

United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711

United States

Divine Providence Hospital

Williamsport, Pennsylvania, 17754

United States

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096

United States

UPMC Memorial

York, Pennsylvania, 17408

United States

Women and Infants Hospital

Providence, Rhode Island, 02905

United States

Smilow Cancer Hospital Care Center - Westerly

Westerly, Rhode Island, 02891

United States

Saint Joseph's/Candler - Bluffton Campus

Bluffton, South Carolina, 29910

United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316

United States

Roper Hospital

Charleston, South Carolina, 29401

United States

Charleston Oncology - Roper

Charleston, South Carolina, 29403

United States

Bon Secours Saint Francis Hospital

Charleston, South Carolina, 29414

United States

Charleston Oncology - Saint Francis

Charleston, South Carolina, 29414

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640

United States

Tidelands Georgetown Memorial Hospital

Georgetown, South Carolina, 29440

United States

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605

United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605

United States

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605

United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615

United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650

United States

South Carolina Cancer Specialists PC

Hilton Head Island, South Carolina, 29926-3827

United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672

United States

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, 38017

United States

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916

United States

Thompson Cancer Survival Center - West

Knoxville, Tennessee, 37932

United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120

United States

Thompson Oncology Group-Oak Ridge

Oak Ridge, Tennessee, 37830

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

United States

Ben Taub General Hospital

Houston, Texas, 77030

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Hematology Oncology Associates of Fredericksburg Inc

Fredericksburg, Virginia, 22408

United States

Bon Secours Memorial Regional Medical Center

Mechanicsville, Virginia, 23116

United States

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, 23114

United States

Bon Secours Saint Mary's Hospital

Richmond, Virginia, 23226

United States

Virginia Cancer Institute

Richmond, Virginia, 23229

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

VCU Community Memorial Health Center

South Hill, Virginia, 23970

United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026

United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029

United States

Providence Regional Cancer System-Lacey

Lacey, Washington, 98503

United States

Swedish Medical Center-First Hill

Seattle, Washington, 98122

United States

Northwest Medical Specialties PLLC

Tacoma, Washington, 98405

United States

Legacy Cancer Institute Medical Oncology and Day Treatment

Vancouver, Washington, 98684

United States

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686

United States

West Virginia University Charleston Division

Charleston, West Virginia, 25304

United States

West Virginia University Healthcare

Morgantown, West Virginia, 26506

United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911

United States

Duluth Clinic Ashland

Ashland, Wisconsin, 54806

United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105

United States

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, 53110

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022

United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024

United States

Bellin Memorial Hospital

Green Bay, Wisconsin, 54301

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303

United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311

United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142

United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051

United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209

United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

United States

ThedaCare Regional Medical Center - Neenah

Neenah, Wisconsin, 54956

United States

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154

United States

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, 54154

United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904

United States

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

United States

Saint Vincent Hospital Cancer Center at Sheboygan

Sheboygan, Wisconsin, 53081

United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495

United States

Aurora Medical Center in Summit

Summit, Wisconsin, 53066

United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241

United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226

United States

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227

United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Erin F Cobain, PRINCIPAL_INVESTIGATOR, SWOG Cancer Research Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2023-11-27

Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2-Negative Breast Carcinoma
Hormone Receptor-Positive Breast Carcinoma