Clinical Trial Protocol Description:
This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are an adult, 18 years of age or older, with HER2-positive breast cancer that is in the breast and nearby lymph nodes only, not spread to other parts of the body.
- After treatment before surgery, there must be no invasive cancer left in the breast or lymph nodes. DCIS only is allowed.
- Have had at least 12 weeks of chemotherapy and trastuzumab before surgery. Some patients may also have had pertuzumab.
- Have had surgery to remove all visible cancer. If a lumpectomy was preformed, must have had or plan to have radiation treatment.
- Are well enough for treatment, including having a good enough heart, liver, kidneys, and bone marrow, based on the doctor’s judgment.
- Are not pregnant or nursing.
- Join the study within 14 weeks after surgery.
- Have no other serious health problems that would make the study unsafe.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Study Details
Clinical Trial Investigator
Contact Information