OncoMatch/Clinical Trials/NCT06845319
Anthracycline-Free Neoadjuvant Chemoimmunotherapy for Triple Negative Breast Cancer Patients
Is NCT06845319 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
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
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 negative or low expression (<10% of invasive cancer cells by IHC) is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative or low expression (<10% of invasive cancer cells by IHC) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative 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.
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