A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer
Clinical Trial Information
Trial Contact: Jobson, Gillian S; Morales, Leticia
IRB No: NRG BR004
Protocol Abbrev: NRG-BR004
Principal Investigator: Ana Elisa Cuesta Fernandez, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: NRG BR004
Treatment: Patients receive pertuzumab intravenously (IV) over 30-60 minutes on day 1, trastuzumab IV over 30-90 minutes on day 1, paclitaxel IV over 60 minutes on days 1, 8, and 15, and atezolizumab IV over 60 minutes on day 1. Courses for pertuzumab, trastuzumab, and atezolizumab repeat every 3 weeks and treatment with paclitaxel repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. Participants may receive additional 6 courses of paclitaxel in the absence of progression at the investigator's discretion.
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT03199885
To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the progression-free survival (PFS)
Adult, HER2-Positive Metastatic Breast Cancer.
ECOG Performance Status of 0 or 1
The tumor specimen obtained at the time of diagnosis of locally recurrent or metastatic disease must have been determined to be HER2-positive based on central testing