The purpose of this study is to compare the effectiveness of 6 months of HER2-targeted medications (trastuzumab with or without pertuzumab) versus 12 months of HER2-targeted medications at reducing the risk of breast cancer coming back or death in patients with early-stage HER2+ breast cancer who had a pCR after preoperative chemotherapy combined with trastuzumab. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach prevents your cancer from coming back compared to the usual approach. Post-surgery trastuzumab with or without pertuzumab is already approved by the FDA for use in early-stage HER2+ breast cancer. There will be about 1524 people taking part in this study.
When you join this study, your doctor will first review your health information to ensure your safety. Throughout the study, you will have regular exams and tests to monitor your health. While most of these are standard care, some are for research purposes only, such as completing two forms. If you speak English or Spanish, you will fill out a form called PROCTCAE about side effects you experience, which helps researchers understand how cancer and its treatment affect people. You will also complete a form about any extra costs you incur during treatment. Since these forms are for research, your answers will not be shared with your study doctor; you should speak directly with your doctor or nurse about any serious health concerns. Your responsibilities as a participant include: keeping all study appointments; reporting all medications, supplements, and any side effects; and informing your doctor of any outside medical visits, hospital stays, or participation in other studies. Finally, you must not become pregnant, breastfeed, or father a child while in the study. You must also inform your study doctor immediately if you or your partner become pregnant during the study or within seven months after your last dose of trastuzumab or pertuzumab.
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA
Jeffrey Aldrich
LCCC - Clinical Trials
Clinical or Medical
Interventional
Cancer (Breast)
25-2392