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OncoMatch/Clinical Trials/NCT07008976

Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer

Is NCT07008976 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including TQB2102 and Trastuzumab Emtansine for for metastatic breast cancer.

Phase 3RecruitingChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.NCT07008976Data as of May 2026

Treatment: TQB2102 · Trastuzumab Emtansine forThis study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression or amplification (IHC 3+ or FISH dual probe positive)

HER2 positive is defined as: immunohistochemical result of 3+ or Fluorescence In Situ Hybridization (FISH) dual probe positive

Allowed: ESR1 expression

HR positive includes ER positive and/or PR positive, that is, the proportion of tumor cells with positive staining among all tumor cells is ≥ 1%

Allowed: PR (PGR) expression

HR positive includes ER positive and/or PR positive, that is, the proportion of tumor cells with positive staining among all tumor cells is ≥ 1%

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: HER2-targeted therapy (anti-HER2 monoclonal antibody) — recurrence/metastasis stage

Received anti-HER2 monoclonal antibody and taxane drugs during the recurrence/metastasis stage. Disease progression occurred during or after the most recent treatment or intolerance. At least 1 line of treatment has been received in the recurrence/metastasis stage.

Must have received: taxane — recurrence/metastasis stage

Received anti-HER2 monoclonal antibody and taxane drugs during the recurrence/metastasis stage. Disease progression occurred during or after the most recent treatment or intolerance. At least 1 line of treatment has been received in the recurrence/metastasis stage.

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

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