OncoMatch/Clinical Trials/NCT06318897
Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
Is NCT06318897 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for stage 1 ct1b-t1cn0m0.
Treatment: Carboplatin · Paclitaxel · Pembrolizumab · Doxorubicin · Cyclophosphamide — To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <10% (<10%)
ER<10%
Required: PR (PGR) expression <10% (<10%)
PR<10%
Required: HER2 (ERBB2) negative (per 2018 ASCO CAP guidelines) (negative)
HER2 negative (per 2018 ASCO CAP guidelines)
Disease stage
Required: Stage I (AJCC 8)
Excluded: Stage II, III, IV
AJCC 8 anatomic tumor Stage 1 T1b-T1c, N0, M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
Cannot have received: systemic anti-cancer therapy
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks to allocation of therapy
Cannot have received: radiation therapy
Exception: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted.
Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids
Lab requirements
Blood counts
ANC ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks)
Kidney function
Creatinine ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Liver function
Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
Adequate organ function as defined in the following table (Table 3)...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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