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OncoMatch/Clinical Trials/NCT05749588

FUSCC Refractory TNBC Platform Study (FUTURE2.0)

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

Phase 2RecruitingFudan UniversityNCT05749588Data as of Jun 2026Location: China

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 ADCThis 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

Treatments studied

Other

A1: SHR-A1811A2: SHR-A1811 with CamrelizumabB1: TROP2 ADCB2: TROP2 ADC with CamrelizumabC1: SHR-A1811C2: SHR-A1811 with BP102D1: TROP2 ADCD2: TROP2 ADC with BP102E1: SHR-A1811F1: TROP2 ADCG1: SHR-A1811H1: TROP2 ADC

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)

Demographics

Female only

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.

Frequently asked questions

Is NCT05749588 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require ESR1?

Yes, ESR1 negative (<1% positive tumor cells by immunohistochemistry) is a required biomarker for enrollment.

Does this trial require PGR?

Yes, PGR negative (<1% positive tumor cells by immunohistochemistry) is a required biomarker for enrollment.

Does this trial require ERBB2?

Yes, ERBB2 negative (0-1+ or 2+ but negative by FISH without amplification) is a required biomarker for enrollment.

Is this trial open to male patients?

No. This trial enrolls female patients only.

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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