OncoMatch/Clinical Trials/NCT06845319
Anthracycline-Free Neoadjuvant Chemoimmunotherapy for Triple Negative Breast Cancer Patients
Is NCT06845319 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Carboplatin and Paclitaxel for triple negative breast cancer.
Treatment: Carboplatin · Paclitaxel · Pembrolizumab — This is a multi-institute, 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
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative or low expression (<10% of invasive cancer cells by IHC) (<10% of invasive cancer cells by IHC)
The invasive tumor must be hormone receptor-negative or low, defined as both estrogen receptor (ER) and or progesterone receptor (PR) staining present in <10% of invasive cancer cells by IHC
Required: PR (PGR) negative or low expression (<10% of invasive cancer cells by IHC) (<10% of invasive cancer cells by IHC)
The invasive tumor must be hormone receptor-negative or low, defined as both estrogen receptor (ER) and or progesterone receptor (PR) staining present in <10% of invasive cancer cells by IHC
Required: HER2 (ERBB2) negative (negative per ASCO-CAP guidelines)
HER2 negativity will be based on current ASCO-CAP guidelines for HER2 testing
Disease stage
Required: Stage II, IIIA, IIIB
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Cannot have received: immunotherapy
Cannot have received: radiation therapy
Cannot have received: surgery
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/uL; Platelets ≥ 100,000/uL; Leukocytes ≥ 3,000/uL; Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks).
Kidney function
Creatinine ≤ 1.5 mg/dL and/or creatinine clearance ≥ 50 mL/min. Patients with CrCl between 30 and 50 mL/min may be eligible at PI discretion.
Liver function
Total bilirubin ≤ 1.5x IULN, OR direct bilirubin ≤ IULN for participants with total bilirubin levels > 1.5x IULN. Participants with a history of Gilbert's disease must have total bilirubin ≤ 5x IULN. AST(SGOT) and ALT(SPGT) ≤ 2.5x IULN.
Cardiac function
Serum albumin ≥ 3.0 g/dL; Baseline neuropathy grade ≤2; EF ≥ 25% at screening
Have adequate organ function at the time of screening visit as defined below: Hematological, Renal, Hepatic, Coagulation, Serum albumin ≥ 3.0 g/dL. Baseline neuropathy grade ≤2. EF ≥ 25% at screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Medical University of South Carolina · Charleston, South Carolina
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