At a glance
ClinicalIndex Comparison Record- ✓Advanced breast cancer with locally recurrent chest wall disease not amenable to surgical excision with curative intent
- ✓Triple negative disease (ER <10%, PR <10%, HER2 negative)
- ✓Hormone receptor positive, HER2 negative disease with progression on at least two prior lines of hormone therapy
- ✓HER2 positive disease with progression on trastuzumab, pertuzumab, T-DM1, and TKI with no other HER2 targeted therapy options available
- ✕Prior checkpoint inhibitor therapy in the metastatic setting
- ✕Active CNS metastases and/or carcinomatous meningitis
- ✕Known hypersensitivity to pembrolizumab or its excipients
- ✕Known hypersensitivity to carboplatin or cisplatin
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Study of Pembrolizumab, an Anti-Programmed Cell Death (PD)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab, Carboplatin, and 1 other intervention for Breast Cancer and Chest Wall Disease. Completed, enrolled 76 participants across 7 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
200 mg Given IV
Arm A: area under the curve (AUC) 5 IV every 3 weeks Arm B: AUC 5 IV every 3 weeks
For HER2+ patients: IV every 3 weeks using standard approved dosing