RECRUITING

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

Conditions

Breast Cancer Breast Neoplasm Breast Cancer Female Breast Cancer Invasive Breast Cancer Stage II Breast Cancer Stage III Triple Negative Breast Cancer Hormone Receptor-positive Breast Cancer HER2-positive Breast Cancer Triple Negative Breast Neoplasms Estrogen 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

The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.

Official Title

A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer

Quick Facts

Study Start:2023-04-18

Study Completion:2029-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05020860

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
* At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible. * Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines). * Tumors must be at least 2 cm by clinical exam or ultrasound * Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician. * ECOG performance status of 0 or 1 * Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan. * Adequate organ function, as determined by the following parameters: * Absolute Neutrophil Count (ANC) ≥ 1200/mm3 * Platelets ≥ 100,000/mm3 * Hemoglobin ≥ 9 g/dL * Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome * Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN * Serum creatinine ≤ institutional ULN * The participant, if of childbearing potential, is willing to use effective, non-hormonal contraception while on treatment. * Participation in a concurrent clinical trial is permitted, with Principal Investigator approval.	* Definitive clinical or radiologic evidence of Stage IV disease * Inflammatory breast cancer * Participants who are pregnant or lactating * History of an excisional biopsy or lumpectomy performed prior to study entry * Prior treatment with anthracyclines for any malignancy. * Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation. * History of cardiac disease that would preclude the use of drugs included in these treatment regimens. This includes, but is not limited to: * Angina pectoris requiring the use of anti-anginal medication * Ventricular arrhythmias except for benign premature ventricular contractions * Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication * Conduction abnormality requiring a pacemaker * Valvular disease with documented compromise in cardiac function * Symptomatic pericarditis * Documented cardiomyopathy * History of documented congestive heart failure (CHF) * Myocardial infarction documented by elevated cardiac enzymes, or persistent regional wall abnormalities on assessment of left ventricular function. * Current HIV, hepatitis B, or hepatitis C infection * History of non-breast malignancies (with the exception of in situ cancers treated only by local excision, and basal cell or squamous cell carcinoma of the skin) within 5 years prior to enrollment. * Any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up. * Any psychiatric or addictive disorders, adverse social situations, or other medical conditions that, in the opinion of the investigator, would preclude the patient from meeting study requirements.

Inclusion Criteria

Exclusion Criteria

* At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.
* Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines).
* Tumors must be at least 2 cm by clinical exam or ultrasound
* Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.
* ECOG performance status of 0 or 1
* Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.
* Adequate organ function, as determined by the following parameters:
* Absolute Neutrophil Count (ANC) ≥ 1200/mm3
* Platelets ≥ 100,000/mm3
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome
* Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN
* Serum creatinine ≤ institutional ULN
* The participant, if of childbearing potential, is willing to use effective, non-hormonal contraception while on treatment.
* Participation in a concurrent clinical trial is permitted, with Principal Investigator approval.

* Definitive clinical or radiologic evidence of Stage IV disease
* Inflammatory breast cancer
* Participants who are pregnant or lactating
* History of an excisional biopsy or lumpectomy performed prior to study entry
* Prior treatment with anthracyclines for any malignancy.
* Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.
* History of cardiac disease that would preclude the use of drugs included in these treatment regimens. This includes, but is not limited to:
* Angina pectoris requiring the use of anti-anginal medication
* Ventricular arrhythmias except for benign premature ventricular contractions
* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
* Conduction abnormality requiring a pacemaker
* Valvular disease with documented compromise in cardiac function
* Symptomatic pericarditis
* Documented cardiomyopathy
* History of documented congestive heart failure (CHF)
* Myocardial infarction documented by elevated cardiac enzymes, or persistent regional wall abnormalities on assessment of left ventricular function.
* Current HIV, hepatitis B, or hepatitis C infection
* History of non-breast malignancies (with the exception of in situ cancers treated only by local excision, and basal cell or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
* Any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up.
* Any psychiatric or addictive disorders, adverse social situations, or other medical conditions that, in the opinion of the investigator, would preclude the patient from meeting study requirements.

Contacts and Locations

Study Contact

Maria Rodriguez

CONTACT

(713) 798-8347

bcc-clinicalresearch@bcm.edu

Principal Investigator

Mothaffar Rimawi, MD

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Harris Health System - Smith Clinic

Houston, Texas, 77054

United States

O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: Baylor Breast Care Center

Mothaffar Rimawi, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

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 Date2023-04-18

Study Completion Date2029-11

Study Record Updates

Study Start Date2023-04-18

Study Completion Date2029-11

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer
Breast Neoplasm
Breast Cancer Female
Breast Cancer Invasive
Breast Cancer Stage II
Breast Cancer Stage III
Triple Negative Breast Cancer
Hormone Receptor-positive Breast Cancer
HER2-positive Breast Cancer
Triple Negative Breast Neoplasms
Estrogen Receptor-positive Breast Cancer