OncoMatch/Clinical Trials/NCT05749588

FUSCC Refractory TNBC Platform Study (FUTURE2.0)

Is NCT05749588 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for triple-negative breast cancer.

Phase 2RecruitingFudan UniversityNCT05749588Data as of May 2026

Treatment: A1: SHR-A1811 · A2: SHR-A1811 with Camrelizumab · B1: TROP2 ADC · B2: TROP2 ADC with Camrelizumab · C1: SHR-A1811 · C2: SHR-A1811 with BP102 · D1: TROP2 ADC · D2: TROP2 ADC with BP102 · E1: SHR-A1811 · F1: TROP2 ADC · G1: SHR-A1811 · H1: TROP2 ADC — This is a Phase II, open-label, Single-center platform study research based on molecular subtypes to explore precision therapy in refractory triple-negative breast cancer.

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Required: ESR1 negative (<1% positive tumor cells by immunohistochemistry) (<1% positive tumor cells by immunohistochemistry)

ER <1% positive tumor cells by immunohistochemistry are defined as ER negative

Required: PR (PGR) negative (<1% positive tumor cells by immunohistochemistry) (<1% positive tumor cells by immunohistochemistry)

PR <1% positive tumor cells are defined as PR negative

Required: HER2 (ERBB2) negative (0-1+ or 2+ but negative by FISH without amplification) (0-1+ or 2+ but negative by FISH without amplification)

HER2 0-1+ or HER2 ++ but negative by FISH without amplification was defined as HER2 negative

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Lab requirements

Blood counts

HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5 x 10^9 /L; PLT ≥75 x 10^9 /L

Kidney function

Serum Cr ≤1×ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula)

Liver function

TBIL ≤1.5×ULN; ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN

The functions of the main organs are basically normal and meet the following conditions: ... see above

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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