New Drug Treatment for HER2-Positive Breast Cancer
A PHASE III, RANDOMIZED, DOULE-BLIND, PLACEO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMA OR PLACBEO AND TRASTUZUMA EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING PREOPERATIVE THERAPY
This study is enrolling participants with a form of breast cancer (HER2-positive breast cancer) to investigate the effectiveness and safety of a medication combination (adjuvant atezolizumab when given in combination with trastuzumab emtansine). This new drug combination may decrease the chances of breast cancer recurrence.
This study has three parts: (1) screening (to determine study eligibility), (2) treatment, and (3) follow-up. Participants will be placed in one of the following treatment groups: (1) one group will receive placebo in combination with trastuzumab emtansine once every 3 weeks for up to 14 cycles (control group) or (2) the other group will receive atezolizumab in combination with trastuzumab emtansine once every 3 weeks for up to 14 cycles (experimental group). For both groups, one treatment “cycle” is 3 weeks long, which means that treatment is given for up to 42 weeks.
This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine for patients with residual invasive HER2-positive breast cancer following neoadjuvant taane-based and HER2-targeted therapy including trastuzumab, who are at high risk of disease recurrence
1) Age greater than or equal to 18 years at time of signing the Informed Consent Form
2) Histologically confirmed invasive breast carcinoma
3) Diagnosis of HER2-positive breast cancer with assessment of hormone receptor and PD-L1 status
4) Completion of preoperative systemic chemotherapy and HER2-directed treatment
5) Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes
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