RECRUITING

A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

Conditions

HER2-positive Breast Cancer Invasive Carcinoma of the Breast Breast Cancer Node Negative Breast Cancer Micrometastasis Breast Cancer Hormone Receptor Positive Breast Cancer

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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 research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer. The study drugs involved in this study are: * A combination of trastuzumab and pertuzumab given as an injection under the skin (PHESGO) * Hormonal (endocrine) Treatment

Official Title

20-347 NCT Number Title A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer (ADEPT)

Quick Facts

Study Start:2021-01-11

Study Completion:2030-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04569747

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
* HER2-positive T1 histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mi) breast cancer according to the AJCC 8th edition anatomic staging table. * If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H\&E or immunohistochemistry (IHC) will be considered node-negative. * Any axillary lymph node with tumor clusters between 0.02 and 0.2cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the Sponsor-Investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record. * Patients who have one or more foci of T1aN0, ER+ (defined as \>10%), HER2-negative cancer in the ipsilateral breast, in addition to their primary HER2-positive tumor, are eligible. * For unifocal disease, all invasive disease must have been tested for ER and PR (for multifocal disease, see below). Either ER or PR must be positive, defined as ER ≥10% or PR ≥10%. ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol. * HER2-positive by ASCO CAP 2018 guidelines. * Bilateral breast cancers that individually meet eligibility criteria are allowed. * Patients with multifocal or multicentric disease are eligible as long as each tumor individually meets eligibility criteria. * Patients with a history of ipsilateral DCIS are eligible as long as the patient has not received prior hormonal therapy. Patients with a history of contralateral DCIS are not eligible unless contralateral DCIS was diagnosed at least 15 years ago * ≤ 95 days between the date of protocol registration and the patient's most recent breast surgery for this breast cancer * Patients must have undergone definitive breast surgery for the current malignancy. All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection * Patients may have received up to 8 weeks of hormonal therapy as adjuvant treatment for this cancer. Patients should otherwise not have received prior hormonal therapy with the exception that hormonal therapy administered for less than 8-week duration at least 15 years ago is allowed. * Prior oophorectomy (including for cancer therapy) is allowed. * Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy. * Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤2 weeks) are eligible. Patients must have discontinued the investigational agent at least 14 days before participation in this study. * Men and women with any menopausal status ≥18 years of age * ECOG Performance Status 0 or 1 * Participants must have normal organ and marrow function as defined below: * ANC ≥ 1000/mm3 * hemoglobin ≥8 g/dl * platelets ≥ 75,000/mm3 * AST and ALT both \<5x institutional ULN * Total bilirubin ≤ 1.5 mg/dL. For patients with Gilbert syndrome, the direct bilirubin should be \<institutional ULN * Serum creatinine ≤ 2.0 mg/dL OR calculated GFR ≥ 30mL/min * Left ventricular ejection fraction (LVEF) ≥ 50% * Post-menopausal patients must meet one of the following criteria: * Prior bilateral ovariectomy/oophorectomy * Age ≥ 60 years * Age \< 60 years with intact uterus and amenorrhoeic for ≥ 12 consecutive months prior to chemotherapy and/or endocrine therapy exposure (medication-induced amenorrhea is not acceptable to meet this criterion) * Age \< 60 years hysterectomized and FSH and plasma estradiol levels in the postmenopausal range according to local policies prior to chemotherapy and/or endocrine therapy exposure. * Willingness to discontinue contraceptive hormonal therapy, e.g. birth control pills, prior to registration and while on study * Premenopausal patients with intact uterus must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and women less than 12 months from their last menstrual period. * Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 7 months after the last dose of antibody treatment and 3 months after the last dose of hormonal treatment. * Patients must be willing and able to sign informed consent. * Patients must be willing to provide archival tissue for research purposes. * If patient is English-speaking, must be willing to fill out patient questionnaires.	* Neoadjuvant or adjuvant chemotherapy for this breast cancer prior to enrollment is prohibited. * Any of the following due to teratogenic potential of the study drugs: * Pregnant women * Nursing women * Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDS, surgical sterilization, abstinence, etc). Hormonal birth control methods are not permitted. * Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc). * Participants who are receiving any other investigational agents for treatment of breast cancer, unless specific approval is obtained from the Sponsor-Investigator. * Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge) * Patients with a history of previous invasive breast cancer. * Individuals with a history of a different malignancy are ineligible except for the following circumstances: * Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. * individuals with the following cancer are eligible regardless of when they were diagnosed and treated: cervical cancer in situ, and non-melanoma cancer of the skin. * Intercurrent illness including, but not limited to: ongoing or active, unresolved systemic infection, renal failure requiring dialysis, active cardiac disease, prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion), history of CHF, current use of any therapy specifically for CHF, uncontrolled hypertension, significant psychiatric illness, or other conditions that in the opinion of the investigator limit compliance with study requirements. * Participant must be enrolled at Dana-Farber Cancer Institute * Participant must not have discontinued pertuzumab following treatment cycle 1 * Participant must be able to tolerate subcutaneous administration following cycle 1

Inclusion Criteria

Exclusion Criteria

* HER2-positive T1 histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mi) breast cancer according to the AJCC 8th edition anatomic staging table.
* If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H\&E or immunohistochemistry (IHC) will be considered node-negative.
* Any axillary lymph node with tumor clusters between 0.02 and 0.2cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the Sponsor-Investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record.
* Patients who have one or more foci of T1aN0, ER+ (defined as \>10%), HER2-negative cancer in the ipsilateral breast, in addition to their primary HER2-positive tumor, are eligible.
* For unifocal disease, all invasive disease must have been tested for ER and PR (for multifocal disease, see below). Either ER or PR must be positive, defined as ER ≥10% or PR ≥10%. ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol.
* HER2-positive by ASCO CAP 2018 guidelines.
* Bilateral breast cancers that individually meet eligibility criteria are allowed.
* Patients with multifocal or multicentric disease are eligible as long as each tumor individually meets eligibility criteria.
* Patients with a history of ipsilateral DCIS are eligible as long as the patient has not received prior hormonal therapy. Patients with a history of contralateral DCIS are not eligible unless contralateral DCIS was diagnosed at least 15 years ago
* ≤ 95 days between the date of protocol registration and the patient's most recent breast surgery for this breast cancer
* Patients must have undergone definitive breast surgery for the current malignancy. All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection
* Patients may have received up to 8 weeks of hormonal therapy as adjuvant treatment for this cancer. Patients should otherwise not have received prior hormonal therapy with the exception that hormonal therapy administered for less than 8-week duration at least 15 years ago is allowed.
* Prior oophorectomy (including for cancer therapy) is allowed.
* Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy.
* Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤2 weeks) are eligible. Patients must have discontinued the investigational agent at least 14 days before participation in this study.
* Men and women with any menopausal status ≥18 years of age
* ECOG Performance Status 0 or 1
* Participants must have normal organ and marrow function as defined below:
* ANC ≥ 1000/mm3
* hemoglobin ≥8 g/dl
* platelets ≥ 75,000/mm3
* AST and ALT both \<5x institutional ULN
* Total bilirubin ≤ 1.5 mg/dL. For patients with Gilbert syndrome, the direct bilirubin should be \<institutional ULN
* Serum creatinine ≤ 2.0 mg/dL OR calculated GFR ≥ 30mL/min
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Post-menopausal patients must meet one of the following criteria:
* Prior bilateral ovariectomy/oophorectomy
* Age ≥ 60 years
* Age \< 60 years with intact uterus and amenorrhoeic for ≥ 12 consecutive months prior to chemotherapy and/or endocrine therapy exposure (medication-induced amenorrhea is not acceptable to meet this criterion)
* Age \< 60 years hysterectomized and FSH and plasma estradiol levels in the postmenopausal range according to local policies prior to chemotherapy and/or endocrine therapy exposure.
* Willingness to discontinue contraceptive hormonal therapy, e.g. birth control pills, prior to registration and while on study
* Premenopausal patients with intact uterus must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and women less than 12 months from their last menstrual period.
* Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 7 months after the last dose of antibody treatment and 3 months after the last dose of hormonal treatment.
* Patients must be willing and able to sign informed consent.
* Patients must be willing to provide archival tissue for research purposes.
* If patient is English-speaking, must be willing to fill out patient questionnaires.

* Neoadjuvant or adjuvant chemotherapy for this breast cancer prior to enrollment is prohibited.
* Any of the following due to teratogenic potential of the study drugs:
* Pregnant women
* Nursing women
* Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDS, surgical sterilization, abstinence, etc). Hormonal birth control methods are not permitted.
* Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc).
* Participants who are receiving any other investigational agents for treatment of breast cancer, unless specific approval is obtained from the Sponsor-Investigator.
* Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)
* Patients with a history of previous invasive breast cancer.
* Individuals with a history of a different malignancy are ineligible except for the following circumstances:
* Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.
* individuals with the following cancer are eligible regardless of when they were diagnosed and treated: cervical cancer in situ, and non-melanoma cancer of the skin.
* Intercurrent illness including, but not limited to: ongoing or active, unresolved systemic infection, renal failure requiring dialysis, active cardiac disease, prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion), history of CHF, current use of any therapy specifically for CHF, uncontrolled hypertension, significant psychiatric illness, or other conditions that in the opinion of the investigator limit compliance with study requirements.
* Participant must be enrolled at Dana-Farber Cancer Institute
* Participant must not have discontinued pertuzumab following treatment cycle 1
* Participant must be able to tolerate subcutaneous administration following cycle 1

Contacts and Locations

Study Contact

Adrienne Waks, MD

CONTACT

617-632-3800

awaks@partners.org

Principal Investigator

Adrienne C Waks, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Stamford Hospital

Stamford, Connecticut, 06904

United States

Winship Cancer Institute at Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Winship Cancer Institute at Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

United States

Indiana University Health Schwarz Cancer Center

Indianapolis, Indiana, 46032

United States

Indiana University Health - Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

United States

Indiana University Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202

United States

Eastern Maine Medical Center (Northern Light)

Brewer, Maine, 04412

United States

Dana Farber Cancer Institite

Boston, Massachusetts, 02115

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Dana-Farber Brigham Cancer Center - Foxborough

Foxboro, Massachusetts, 02035

United States

Cape Cod Healthcare Center

Hyannis, Massachusetts, 02601

United States

Dana-Farber at Milford

Milford, Massachusetts, 01757

United States

Dana-Farber at South Shore Hospital

Weymouth, Massachusetts, 02190

United States

Dana-Farber Cancer Insitute at Londonderry Hospital

Londonderry, New Hampshire, 03053

United States

New York University Langone Hospital -Brooklyn

Brooklyn, New York, 11220

United States

New York University Langone Hospital - Long Island

Mineola, New York, 11501

United States

New York University Langone Health

New York, New York, 10016

United States

UNC Rex Hematology Oncology Associated - Cary

Cary, North Carolina, 27518

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

UNC Rex Hematology Oncology Associates of Garner

Garner, North Carolina, 27529

United States

UNC Rex Cancer Center

Raleigh, North Carolina, 27607

United States

UNC Rex Cancer Center at Wakefield

Raleigh, North Carolina, 27614

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

SCRI Oncology Partners

Nashville, Tennessee, 37203

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37203

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Adrienne C Waks, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

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 Date2021-01-11

Study Completion Date2030-09-01

Study Record Updates

Study Start Date2021-01-11

Study Completion Date2030-09-01

Terms related to this study

Keywords Provided by Researchers

HER2-positive Breast Cancer
Invasive Carcinoma of the Breast
Breast Cancer
Node Negative Breast Cancer
Micrometastasis Breast Cancer
Hormone Receptor Positive Breast Cancer

Additional Relevant MeSH Terms

HER2-positive Breast Cancer
Invasive Carcinoma of the Breast
Breast Cancer
Node Negative Breast Cancer
Micrometastasis Breast Cancer
Hormone Receptor Positive Breast Cancer