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OncoMatch/Clinical Trials/NCT06649331

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

Is NCT06649331 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for advanced breast cancer.

Phase 2RecruitingFudan UniversityNCT06649331Data as of May 2026

Treatment: SHR-A1811 · SHR-A1921 · SHR-A2009 · SHR-A2102 · Famitinib · Trastuzumab (or biosimilar) · 9MW2821This is a prospective, open-label, multicenter, phase II platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously used antibody-conjugated drugs.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Triple-Negative Breast Cancer

Biomarker criteria

Allowed: ESR1 expression

Participants with any hormone receptor (HR) status will be allowed on study

Allowed: PR (PGR) expression

Participants with any hormone receptor (HR) status will be allowed on study

Allowed: HER2 (ERBB2) expression

The most recent pathology results will be considered for enrollment according to local testing of ER, PR and HER2

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: antibody-drug conjugate

Previously received ADCs

Must have received: CDK4/6 inhibitor

Participants with HR-positive breast cancer must have received prior CDK4/6 inhibitor

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 ≤1.5×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

Cardiac function

lvef≥50%

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

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