OncoMatch/Clinical Trials/NCT06845319
NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients
Is NCT06845319 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Carboplatin and Paclitaxel for triple negative breast cancer.
Treatment: Carboplatin · Paclitaxel · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (≤10% by IHC)
estrogen receptor (ER) and/or progesterone receptor (PR) staining present in ≤10% of invasive cancer cells by immunohistochemistry (IHC)
Required: PR (PGR) expression (≤10% by IHC)
estrogen receptor (ER) and/or progesterone receptor (PR) staining present in ≤10% of invasive cancer cells by immunohistochemistry (IHC)
Required: HER2 (ERBB2) wild-type
HER2-negative disease, defined in accordance with current ASCO-CAP HER2 guidelines
Disease stage
Required: Stage II, IIIA, IIIB
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: diagnostic core or vacuum-assisted biopsies allowed
No prior chemotherapy, immunotherapy, radiation therapy, or surgery for the current breast cancer (diagnostic core or vacuum-assisted biopsies allowed)
Cannot have received: immunotherapy
Exception: diagnostic core or vacuum-assisted biopsies allowed
No prior chemotherapy, immunotherapy, radiation therapy, or surgery for the current breast cancer (diagnostic core or vacuum-assisted biopsies allowed)
Cannot have received: radiation therapy
Exception: diagnostic core or vacuum-assisted biopsies allowed
No prior chemotherapy, immunotherapy, radiation therapy, or surgery for the current breast cancer (diagnostic core or vacuum-assisted biopsies allowed)
Cannot have received: surgery
Exception: diagnostic core or vacuum-assisted biopsies allowed
No prior chemotherapy, immunotherapy, radiation therapy, or surgery for the current breast cancer (diagnostic core or vacuum-assisted biopsies allowed)
Lab requirements
Blood counts
ANC ≥1,500/µL; platelets ≥100,000/µL; leukocytes ≥3,000/µL; hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (no erythropoietin dependency or transfusion within 14 days)
Kidney function
Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min (30-50 mL/min at PI discretion)
Liver function
AST (SGOT) and ALT (SGPT) ≤2.5 × ULN; serum albumin ≥3.0 g/dL; total bilirubin ≤1.5 × IULN or ≤5 × ULN if Gilbert's syndrome
Adequate organ function at the time of screening, defined as: Hematologic: ANC ≥1,500/µL, platelets ≥100,000/µL, leukocytes ≥3,000/µL, hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (without erythropoietin dependency and without packed red blood cell transfusion within 14 days prior to testing). Renal: Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min. Patients with creatinine clearance 30-50 mL/min may be enrolled at the discretion of the Principal Investigator. Hepatic: AST (SGOT) and ALT (SGPT) ≤2.5 × ULN; serum albumin ≥3.0 g/dL; total bilirubin ≤1.5 × IULN or ≤5 × ULN if Gilbert's syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Medical University of South Carolina · Charleston, South Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06845319 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or IIIA or IIIB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify