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
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. .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
375
Trastuzumab + pertuzumab SC FDC (PHESGO) will be administered on Day 1 of each 21-day cycle , subcutaneous, fixed dose
Oral, daily per cycle
Stamford Hospital
Stamford, Connecticut, United States
RECRUITINGUniversity of Miami- Sylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGWinship Cancer Institute at Emory University Hospital Midtown
Atlanta, Georgia, United States
RECRUITINGEmory University - Winship Cancer Institute
Atlanta, Georgia, United States
Invasive Disease Free Survival at 3 Years
Kaplan-Meier estimates of iDFS will be estimated and plotted with the corresponding 95% confidence intervals. from the time of randomization until the occurrence of the first of the following events: invasive local/regional recurrence, Contralateral invasive breast cancer, Distant recurrence, Death from any cause
Time frame: 3 Years
Invasive Disease Free Survival at 7 Years
Kaplan-Meier estimates of iDFS will be estimated and plotted with the corresponding 95% confidence intervals. from the time of randomization until the occurrence of the first of the following events: invasive local/regional recurrence, Contralateral invasive breast cancer, Distant recurrence, Death from any cause
Time frame: 7 years
Invasive Disease Free Survival at 10 Years
Kaplan-Meier estimates of iDFS will be estimated and plotted with the corresponding 95% confidence intervals. from the time of randomization until the occurrence of the first of the following events: invasive local/regional recurrence, Contralateral invasive breast cancer, Distant recurrence, Death from any cause
Time frame: 10 years
Recurrence-free interval (RFI) at 3 Years
RFI will be estimated and plotted with the corresponding 95% confidence intervals, using Kaplan-Meier estimates for the study as a whole and for subgroups of patients determined by intrinsic subtype (HER2-enriched, luminal, basal Time of randomization until the occurrence of the first of the following events:Invasive local/regional recurrence, Distant recurrence, Death from breast cancer
Time frame: 3 Years
Recurrence-free interval (RFI) at 7 Years
RFI will be estimated and plotted with the corresponding 95% confidence intervals, using Kaplan-Meier estimates for the study as a whole and for subgroups of patients determined by intrinsic subtype (HER2-enriched, luminal, basal Time of randomization until the occurrence of the first of the following events:Invasive local/regional recurrence, Distant recurrence, Death from breast cancer
Time frame: 7 Years
Recurrence-free interval (RFI) at 10 Years
RFI will be estimated and plotted with the corresponding 95% confidence intervals, using Kaplan-Meier estimates for the study as a whole and for subgroups of patients determined by intrinsic subtype (HER2-enriched, luminal, basal Time of randomization until the occurrence of the first of the following events:Invasive local/regional recurrence, Distant recurrence, Death from breast cancer
Time frame: 10 Years
Breast cancer-specific survival (BCSS) at 3 Years
defined as the time period between randomization and death due to breast cancer.
Time frame: 3 Years
Breast cancer-specific survival (BCSS) at 7 Years
defined as the time period between randomization and death due to breast cancer.
Time frame: 7 Years
Breast cancer-specific survival (BCSS) at 10 Years
defined as the time period between randomization and death due to breast cancer.
Time frame: 10 Years
Overall survival
OS will be estimated and plotted with the corresponding 95% confidence intervals, using Kaplan-Meier estimates for the study as a whole and for subgroups of patients determined by intrinsic subtype (HER2-enriched, luminal, basal).
Time frame: randomization and death. Surviving patients classified as lost-to-follow-up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first up to 10 years
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
Time frame: baseline to 5 Years
Total patient chair time of drug administration
Mean difference will be estimated between HP FDC SC and IV admin of HP in sub-study
Time frame: baseline to 18 Months
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Winship Cancer Institute at Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
RECRUITINGUniversity of Chicago Medical Center
Chicago, Illinois, United States
RECRUITINGIndiana University Health Schwarz Cancer Center
Indianapolis, Indiana, United States
RECRUITINGIndiana University Health - Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
RECRUITINGIndiana University Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States
RECRUITINGEastern Maine Medical Center (Northern Light)
Brewer, Maine, United States
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