A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

Part of paid clinical trials in Stanford, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT03125902
Phase
PHASE3
Status
Completed

Conditions

  • Triple-Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody — DRUG
    Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
  • Atezolizumab Placebo — DRUG
    Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
  • Paclitaxel — DRUG
    Paclitaxel will be administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle.

Study Details

This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 \[PD-L1\] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.

Key Dates

Start date
Aug 25, 2017
Status verified
Mar 2024
Primary completion
Nov 15, 2019
Completion
Jan 17, 2023

Study Design

Enrollment
653 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo and Paclitaxel
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
  • Experimental: Atezolizumab and Paclitaxel
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status [ Time Frame: From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Stanford Cancer CenterStanfordCalifornia94305-5820-
Florida Cancer Specialists; Department of OncologyFort MyersFlorida33901-8101-
Florida Cancer Specialist, North RegionSt. PetersburgFlorida33705-
Northwest Georgia Oncology Centers PC - MariettaMariettaGeorgia30060-
HCA Midwest HealthKansas CityMissouri64132-
The Valley HospitalParamusNew Jersey07652-
Magee-Woman's HospitalPittsburghPennsylvania15213-
Tennessee Oncology; Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Stanford, CA

By research site
Stanford Cancer Center· Stanford, CAFlorida Cancer Specialists; Department of Oncology· Fort Myers, FLFlorida Cancer Specialist, North Region· St. Petersburg, FLNorthwest Georgia Oncology Centers PC - Marietta· Marietta, GAHCA Midwest Health· Kansas City, MOThe Valley Hospital· Paramus, NJ

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