New Drug Treatment for HER2-Positive Breast Cancer
Protocol: STUDY00005266
Full Title
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
Description
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.
Compensation: No
Eligibility
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
Age Group: Adults
Principal Investigator: Robert Setlik
Contact(s)
Ashlee Lang
alang@kaleidahealth.org
+1 716-859-8519
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