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OncoMatch/Clinical Trials/NCT06081959

Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer

Is NCT06081959 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for metastatic breast cancer.

Phase 3RecruitingSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.NCT06081959Data as of May 2026

Treatment: SKB264 · Eribulin · Capecitabine · Gemcitabine · VinorelbineThe purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) negative

Required: ESR1 positive

Required: PR (PGR) positive

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic chemotherapy — unresectable locally advanced, recurrent, or metastatic

Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage

Cannot have received: TROP2 targeted therapy

Prior TROP2 targeted therapy

Cannot have received: topoisomerase I inhibitor

prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy

Lab requirements

Blood counts

adequate organ and bone marrow function

Kidney function

adequate organ and bone marrow function

Liver function

adequate organ and bone marrow function

Adequate organ and bone marrow function

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

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