OncoMatch/Clinical Trials/NCT06636981
All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial
Is NCT06636981 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cohort2: ATRA+Toripalimab+TPC and Cohort1: ATRA+Toripalimab+chemo for triple negative breast cancer (tnbc).
Treatment: Cohort2: ATRA+Toripalimab+TPC · Cohort1: ATRA+Toripalimab+chemo — All trans retinoic acid Combined with Toripalimab+Chemotherapy for Locally Advanced inoperable or Metastatic Triple Negative Breast Cancer：a multi-center, multi-cohort phase II trial
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (IHC ER<1%) (IHC <1%)
ER negativity is defined as: IHC ER<1%
Required: PR (PGR) negative (IHC PR<1%) (IHC <1%)
PR negativity is defined as: IHC PR<1%
Required: HER2 (ERBB2) negative (IHC 0 or 1+; or IHC 2+ with FISH negative) (IHC 0 or 1+; or IHC 2+ with FISH negative)
Her-2 negativity is defined as: immunohistochemical detection of Her-2 (-) or (1+), Her-2 (2+) must undergo FISH testing and the result is negative
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified) (testing required; no eligibility threshold specified)
retrospective biomarker analysis (including PD-L1 expression levels)
Disease stage
Required: Stage III, IV (AJCC 8th edition)
locally advanced inoperable or metastatic breast cancer confirmed by histology (according to AJCC 8th edition staging)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Individuals who have previously been treated with PD-1 or PD-L1 monoclonal antibodies
Cannot have received: anti-PD-L1 therapy
Individuals who have previously been treated with PD-1 or PD-L1 monoclonal antibodies
Cannot have received: taxane (albumin paclitaxel)
Exception: Cohort 1 only
Participants in cohort 1 who have previously used albumin paclitaxel
Lab requirements
Blood counts
platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 90g/L, neutrophil count (ANC) ≥ 1.5 × 10^9/L
Kidney function
serum creatinine ≤ 1.5 ULN, or creatinine clearance rate ≥ 60mL/min (Cockcroft Gault formula)
Liver function
AST and ALT ≤ 2.5 x ULN, ≤ 5 x ULN if liver metastasis is present; total bilirubin ≤ 1.5 x ULN
platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 90g/L, neutrophil count (ANC) ≥ 1.5 × 10^9/L AST and ALT ≤ 2.5 x ULN, ≤ 5 x ULN if liver metastasis is present, total bilirubin ≤ 1.5 x ULN, serum creatinine ≤ 1.5 ULN, or creatinine clearance rate ≥ 60mL/min (Cockcroft Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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