Spots Global Cancer Trial Database for 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
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Trial Identification
Brief 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
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)
Study ID: NCT04569747
Study Description
Brief 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
Detailed Description: The research study procedures include screening for eligibility and study treatment including laboratory evaluations, physical exams, questionnaires, and follow up visits. * Participants will receive HER2-directed treatment for 1 year and hormonal therapy for approximately 5 years. * It is expected that about 375 people will take part in this research study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug works in treating a specific disease. "Investigational" means that the drug combination is being studied. The drugs trastuzumab and pertuzumab are both monoclonal antibodies, which are disease-fighting proteins made by cloned immune cells. The U.S. Food and Drug Administration (FDA) has approved trastuzumab, pertuzumab, and trastuzumab + pertuzumab subcutaneous fixed dose combination (PHESGO) as treatment for HER2 positive breast cancer. The FDA has also approved hormonal therapies as treatment for hormone receptor positive breast cancer. .
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stamford Hospital, Stamford, Connecticut, 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
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, Foxboro, 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
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Adrienne C Waks, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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