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OncoMatch/Clinical Trials/NCT06954961

A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer

Is NCT06954961 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including D-0502 and Fulvestrant for breast cancer.

Phase 3RecruitingInventisBio Co., LtdNCT06954961Data as of May 2026

Treatment: D-0502 · FulvestrantThis is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast cancer with fulvestrant injection as a control drug.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) negative

Required: ESR1 positive

Prior therapy

Must have received: endocrine therapy — adjuvant or metastatic

disease recurrence during or after adjuvant endocrine therapy, or whose disease has progressed after 1-2 lines of systemic endocrine therapy

Cannot have received: systemic chemotherapy

Exception: no more than 2 prior systemic chemotherapy

Subjects with locally advanced or metastatic breast cancer who have previously received more than 2 prior systemic chemotherapy

Cannot have received: selective estrogen receptor degrader (SERD)/selective estrogen receptor covalent antagonist (SERCA) (fulvestrant, GDC-9545, AZD9833, SAR-439859, Zn-c5, LX-039, HS234)

Prior treatment with a selective estrogen receptor degrader (SERD)/selective estrogen receptor covalent antagonist (SERCA), such as fulvestrant, GDC-9545, AZD9833, SAR-439859, Zn -c5, LX-039, HS234, etc.

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

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