Carboplatin With or Without Atezolizumab in Treating Patients With Stage IV Triple Negative Breast Cancer

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT03206203
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Given by vein
  • Carboplatin — DRUG
    Given by vein
  • Laboratory Biomarker — OTHER
    Correlative study
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

This randomized phase II trial studies how well carboplatin with or without atezolizumab works in treating patients with stage IV triple negative breast cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving carboplatin with atezolizumab may work better in treating patients with stage IV triple negative breast cancer

Key Dates

Start date
Aug 29, 2017
Status verified
Nov 2024
Primary completion
Nov 30, 2022
Completion
Oct 4, 2023

Study Design

Enrollment
106 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 (atezolizumab, carboplatin)
    Patients receive atezolizumab IV over 30-60 minutes and carboplatin IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm 2 (atezolizumab, carboplatin)
    Patients receive carboplatin as in Arm 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may cross-over to Arm 1 upon disease progression.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 3 years. ]

Locations (6)

FacilityCityStateZIPSite coordinators
Georgetown University Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20057-
Indiana University Health Melvin Bren Simon Cancer CenterIndianapolisIndiana46202-
Johns Hopkins University Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Washington D.C., DC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Georgetown University Lombardi Comprehensive Cancer Center· Washington D.C., DCIndiana University Health Melvin Bren Simon Cancer Center· Indianapolis, INJohns Hopkins University Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDUniversity of North Carolina at Chapel Hill· Chapel Hill, NCUniversity of Pennsylvania· Philadelphia, PAVanderbilt-Ingram Cancer Center· Nashville, TN

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