At a glance
ClinicalIndex Comparison Record- ✓Triple-negative breast cancer (hormone receptor negative and HER-2 negative) with metastatic disease and no prior chemotherapy for metastatic disease
- ✓HER-2 negative confirmed by IHC (0 or 1+) or FISH (non-amplified) per ASCO/CAP guidelines
- ✓Circulating tumor cells ≥5
- ✓Measurable disease by RECIST 1.1
- ✕HER2-positive disease (3+ by IHC or amplified by FISH)
- ✕Prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy
- ✕Prior anti-cancer monoclonal antibody within 4 weeks of study start or unrecovered toxicity
- ✕Prior chemotherapy, targeted therapy, or radiation within 14 days of registration or unrecovered toxicity (except grade ≤2 neuropathy)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells (CTCs) Positive Her-2 Negative Metastatic Breast Cancer (MBC)
In Brief
A Phase 2 clinical trial evaluating Carboplatin, Laboratory Biomarker Analysis, and 1 other intervention for Estrogen Receptor Negative and 6 related conditions. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast cancer previously treated with anthracyclines and taxanes. Previous studies have indicated that recurrent breast cancers are more resistant to chemotherapy and maybe associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells. Pembrolizumab has been found effective in other types of cancer and has already been approved by FDA for those indications, but the efficacy in breast cancer is still unknown. In this study, pembrolizumab will be combined with chemotherapy to increase the cancer cell killing. There is no control or placebo treatment in this study.
Study Details
Timeline
Arms & Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Correlative studies
Given IV