A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy

Part of paid clinical trials in Orange, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT02924883
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 mg IV infusion
  • Trastuzumab emtansine — DRUG
    Trastuzumab emtansine 3.6 mg/kg IV infusion
  • Placebo — OTHER
    Placebo matched to atezolizumab

Study Details

This Phase II, double-blind, randomized, placebo-controlled multicenter study will investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic BC who have received prior trastuzumab and taxane based therapy, either alone or in combination, and/or who have progressed within 6 months after completing adjuvant therapy.

Key Dates

Start date
Sep 26, 2016
Status verified
Jan 2021
Primary completion
Dec 11, 2017
Completion
Feb 6, 2020

Study Design

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

Arms

  • Experimental: Trastuzumab Emtansine + Atezolizumab
    Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion or matching Placebo followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (approximately 29 months)
  • Active Comparator: Trastuzumab Emtansine + Placebo
    Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (approximately 29 months)

Primary Outcome Measure

Progression-Free Survival (PFS) as Determined by Investigator's Tumor Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) [ Time Frame: Baseline up to approximately 15 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
Breastlink Med Group IncOrangeCalifornia92868-
University of ColoradoAuroraColorado80045-
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)Washington D.C.District of Columbia20007-
SCRI Florida Cancer Specialists SouthFort MyersFlorida33916-
Florida Cancer Specialists; Saint PetersburgSt. PetersburgFlorida33719-
Northside HospitalAtlantaGeorgia30342-
Johns Hopkins Univ Med CenterBaltimoreMaryland21231-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.New YorkNew York10016-
Ohio State Uni Medical CenterColumbusOhio43210-
Magee Womens HospitalPittsburghPennsylvania15213-
Cancer Care Associates of YorkYorkPennsylvania17403-
SCRI Tennessee Oncology ChattanoogaChattanoogaTennessee37404-
Tennessee Oncology; Sarah Cannon Research InstituteNashvilleTennessee37203-
University of WashingtonSeattleWashington98195-

Find similar trials in Orange, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Breastlink Med Group Inc· Orange, CAUniversity of Colorado· Aurora, COMedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)· Washington D.C., DCSCRI Florida Cancer Specialists South· Fort Myers, FLFlorida Cancer Specialists; Saint Petersburg· St. Petersburg, FLNorthside Hospital· Atlanta, GA

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