Study ID: NRG BR004
Randomized, double-blind, phase III trial of paclitaxel/trastuzumab/pertuzumab with either atezolizumab or placebo in first-line HER2-positive metastatic breast cancer.
Researchers are studying the effectiveness of treating patients diagnosed with HER2-positive metastatic breast cancer with a combination of FDA-approved medications.
All study participants are administered the monocloncal antibody medications trastuzumab and Perjet ® (pertuzumab) and the anti-cancer drug Taxol® (paclitaxel). Patients are then randomized into two study groups. Those in Experimental Arm 1 are also administered another monoclonal antibody, the drug Tecentriq® (atezolizumab). Those in Experimental Arm 2 receive a placebo.
Participants undergo regularly scheduled treatments and follow-up care.
Patients must undergo a bone scan and CT imaging of the chest, abdomen and pelvis within four weeks before randomization into the trial.
This phase III randomized study seeks to determine if treatment with Tecentriq® (atezolizumab) can result in progression-free survival among patients with histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease.
All study participants receive the following treatment regimen:
- pertuzumab IV over 30-60 minutes on days one and 22
- trastuzumab IV over 30-90 minutes on days one and 22
- paclitaxel IV over 60 minutes on days one, eight, 15, 22, 29, and 36
Participants in Experimental Arm 1 also receive atezolizumab IV over 60 minutes on day one and 30 minutes on day 22. Cycles for pertuzumab, trastuzumab and atezolizumab repeat every six weeks.
Those in Experiment Arm 2 (the active comparator arm) receive placebo IV over 60 minutes on days one and 30 minutes on day 22. Cycles for pertuzumab, trastuzumab and placebo repeat every six weeks.
For patients in both study arms, treatment with paclitaxel repeats every six weeks for up to four cycles. Patients may receive additional three cycles of paclitaxel in the absence of disease progression.
- Must have been diagnosed with HER2-positive metastatic breast cancer and have measurable disease based on RECIST 1.1
- Women of child-bearing potential and men must agree to use adequate contraception (non-hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for several months after the study
- Other inclusion and exclusion criteria apply