Pembrolizumab With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease

Part of paid clinical trials in San Francisco, California.

Sponsor
Laura Huppert, MD, BA
Study ID
NCT03095352
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — BIOLOGICAL
    200 mg Given IV
  • Carboplatin — DRUG
    Arm A: area under the curve (AUC) 5 IV every 3 weeks Arm B: AUC 5 IV every 3 weeks
  • Trastuzumab — BIOLOGICAL
    For HER2+ patients: IV every 3 weeks using standard approved dosing

Study Details

This is a phase II multicenter study including breast cancer patients with chest wall disease that is hormone resistant (estrogen receptor (ER) positive/progesterone receptor (PR) positive/human epidermal growth factor receptor 2 (HER2) negative breast cancer with progressive disease on 2 prior lines of hormonal therapy) or triple negative (ER negative/PR negative/HER2 negative, TNBC). A companion translational study is operating concurrently with the study described above. In this study, biomarker research to be performed on tumor biopsies and peripheral blood samples will be performed to explore the immunologic and genomic mechanism of action underlying treatment with pembrolizumab and carboplatin versus carboplatin alone. This protocol includes tissue and blood correlative exploratory endpoints including changes in tumor PD-L1 (programmed death ligand 1) gene expression, tumor and peripheral blood immune composition and cytokine expression, plasma tumor DNA, circulating tumor cells, and tumor myelocytomatosis (MYC) oncogene expression using tumor biopsy and peripheral blood testing before and after treatment; correlations with these markers and disease control rate will be assessed.

Key Dates

Start date
Sep 2, 2017
Status verified
Nov 2025
Primary completion
Nov 30, 2024
Completion
Nov 30, 2024

Study Design

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

Arms

  • Experimental: Arm A: Pembrolizumab + Carboplatin
    Participants receive carboplatin intravenously (IV) and pembrolizumab IV over 30 minutes on day 1. Participants who are HER2+ also receive trastuzumab IV every 3 weeks. Treatment repeats every 3 weeks for a least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of carboplatin and pembrolizumab, participants with stable or responding disease receive pembrolizumab monotherapy on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm B: Carboplatin Monotherapy
    Participants receive carboplatin on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Disease Control Rate (DCR) at 18 Weeks [ Time Frame: Up to 18 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-
Georgetown University HospitalWashington D.C.District of Columbia20007-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Indiana University/Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Massachusetts General HospitalBostonMassachusetts02114-
University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-

Related coverage on Hipa.ai

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By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of California, San Francisco· San Francisco, CAGeorgetown University Hospital· Washington D.C., DCUniversity of Chicago Comprehensive Cancer Center· Chicago, ILIndiana University/Melvin and Bren Simon Cancer Center· Indianapolis, INMassachusetts General Hospital· Boston, MAUniversity of Pittsburgh Cancer Institute· Pittsburgh, PA

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