RecruitingPhase 2NCT04569747

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

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)

Sponsor

Dana-Farber Cancer Institute

Enrollment

375 participants

Start Date

Jan 11, 2021

Study Type

INTERVENTIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a hormone therapy and two targeted drugs (pertuzumab and trastuzumab) used after surgery for a specific type of early-stage breast cancer that is HER2-positive and hormone receptor-positive, but small enough that chemotherapy may not be needed. **You may be eligible if...** - You have been diagnosed with HER2-positive, hormone receptor-positive (ER or PR ≥10%) invasive breast cancer - Your tumor is stage I (T1) with no lymph node involvement or only tiny amounts (micrometastases) - You have had surgery to remove the cancer - You have not received prior chemotherapy or targeted therapy for this cancer **You may NOT be eligible if...** - Your cancer has spread beyond the breast or nearby lymph nodes - Your cancer is HER2-negative or hormone receptor-negative - You have a history of prior breast cancer treated with chemotherapy or HER2-targeted drugs - You have had prior radiation to the breast that would prevent further treatment - You have serious heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTPertuzumab+TRASTUZUMAB

Trastuzumab + pertuzumab SC FDC (PHESGO) will be administered on Day 1 of each 21-day cycle , subcutaneous, fixed dose

DRUGADJUVANT ENDOCRINE THERAPY

Oral, daily per cycle

Locations(32)

Stamford Hospital

Stamford, Connecticut, United States

University of Miami- Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Winship Cancer Institute at Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States

Winship Cancer Institute at Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Indiana University Health Schwarz Cancer Center

Indianapolis, Indiana, United States

Indiana University Health - Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Indiana University Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

Eastern Maine Medical Center (Northern Light)

Brewer, Maine, United States

Dana Farber Cancer Institite

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Brigham Cancer Center - Foxborough

Foxborough, Massachusetts, United States

Cape Cod Healthcare Center

Hyannis, Massachusetts, United States

Dana-Farber at Milford

Milford, Massachusetts, United States

Dana-Farber at South Shore Hospital

Weymouth, Massachusetts, United States

Dana-Farber Cancer Insitute at Londonderry Hospital

Londonderry, New Hampshire, United States

New York University Langone Hospital -Brooklyn

Brooklyn, New York, United States

New York University Langone Hospital - Long Island

Mineola, New York, United States

New York University Langone Health

New York, New York, United States

UNC Rex Hematology Oncology Associated - Cary

Cary, North Carolina, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

UNC Rex Hematology Oncology Associates of Garner

Garner, North Carolina, United States

UNC Rex Cancer Center

Raleigh, North Carolina, United States

UNC Rex Cancer Center at Wakefield

Raleigh, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Greco-Hainsworth Centers for Research/Tennessee Oncology

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine Medical Center

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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