Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-136
Prinicipal Investigator
Vasekar, Monali
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
BR004
Title
A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer
Objective
To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the progression-free survival (PFS), assessed by investigator using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo in patients with newly documented HER2-positive measurable metastatic breast cancer.

Secondary Objectives
To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the overall survival (OS) relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.
To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the overall objective response (OR), assessed by investigator using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.
To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve PFS, OR, and/or duration of objective response assessed by retrospective blinded central review using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.
To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will decrease the incidence of subsequent brain metastases in patients without known brain metastases at study entry relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.
To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will contribute to increased patient-reported fatigue in comparison to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.
To determine the utility of PD-L1 IHC staining as a predictive and prognostic biomarker associated with clinical response, as assessed by investigator using RECIST 1.1 criteria, to atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab.
To determine the immune-related toxicity profile of the two treatment regimens.
To determine the cardiac safety profile of the two treatment regimens.

Exploratory Objectives
To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the progression-free survival and overall objective response, assessed by investigator using iRECIST criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.
To identify potential biomarkers that can predict benefit from the addition of atezolizumab in patients with newly documented HER2-positive measurable metastatic breast cancer treated with a regimen of paclitaxel, pertuzumab, and trastuzumab, and placebo.
To explore the toxicity profile of the two treatment regimens using patient-reported symptomatic adverse events in addition to standard adverse event reports.
To determine the feasibility and added value of frequent assessment of toxicity using PRO-CTCAE with ePRO reporting.
Applicable Disease Sites
Breast
Status
Open
Participating Institutions
Hershey Medical Center