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 — DRUG
    Carboplatin 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 — DRUG
    80mg/m2 weekly
  • Pembrolizumab — DRUG
    200 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

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Casey Charlton

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