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Trial Summary


Protocol No.TBCRC044
StatusSUSPENDED
Principal InvestigatorMiller, Kathy
ScopeNational
PhasePhase II
Age GroupAdult
TitleA Randomized Phase II Study of Pembrolizumab, an anti-PD (programmed cell death)-1 Antibody, in Combination with Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients with Chest Wall Disease
DescriptionThis is a phase II multicenter study including breast cancer patients with chest wall disease that is hormone resistant (ER positive/PR positive/HER2 negative breast cancer with progressive disease on 2 prior lines of hormonal therapy) or triple negative (ER negative/PR negative/HER2 negative, TNBC). Eighty-four patients will be enrolled at Translational Breast Cancer Research Consortium (TBCRC) sites and will be randomized 2:1 to receive treatment with pembrolizumab and carboplatin (n=56, Arm A) or carboplatin alone (n=28, Arm B) until documented disease progression. Patients randomized to Arm B may cross-over following progression to pembrolizumab alone (Arm Bx). Patients may have received any number of prior lines of chemotherapy. Patients in Arm A will be treated with pembrolizumab 200 mg IV and carboplatin AUC 5 IV every 3 weeks for at least 6 cycles followed by maintenance pembrolizumab 200 mg IV every 3 weeks if stable or responding disease. Patients in Arm B will be treated with carboplatin AUC 5 IV every 3 weeks until progression, whereupon they may cross-over to pembrolizumab 200 mg IV every 3 weeks alone (Arm Bx). An interim analysis for futility will be performed after 18 patients are enrolled into Arm B to allow early stopping of that trial arm for lack of efficacy. The primary endpoint is to compare disease control rates at 18 weeks of treatment. Secondary endpoints include progression free survival, toxicity, and overall response rate.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Advanced breast cancer with locally recurrent chest wall disease not amenable to surgical excision.
  • At least two weeks from last systemic therapy for breast cancer, with recovery of all treatment related toxicity to grade 1 or less. Subjects with ≤ Grade 2 neuropathy are an exception to this criterion.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesBreast
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu