NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- Medical University of South Carolina
- Study ID
- NCT06845319
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Carboplatin — DRUGCarboplatin target AUC 5 every 3 weeks for 12-18 weeks OR target AUC 1.5 every week for 12-18 weeks (per investigator's choice).
- Paclitaxel — DRUG80mg/m2 weekly
- Pembrolizumab — DRUG200 mg every 3 weeks for 4 cycles
Study Details
This is a single-arm Phase II study to assess the efficacy of a 12-18 week neoadjuvant carboplatin, paclitaxel, and pembrolizumab (CPP) regimen in a response-adaptive manner for triple-negative breast cancer (TNBC) patients who are ineligible for anthracycline-based therapy due to underlying cardiac conditions.
Key Dates
- Start date
- Oct 20, 2025
- Status verified
- May 2026
- Primary completion
- Oct 20, 2027
- Completion
- Oct 20, 2028
Study Design
- Enrollment
- 43 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TNBC + non inflammatory Stage 2 3A/B
Primary Outcome Measure
pCR Rate in TNBC patients [ Time Frame: 18 weeks ]
Central Contacts
- Abirami Sivapiragasam843-792-9300
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Casey Charlton |
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