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.
Treatment: TQB2102 · Trastuzumab Emtansine for — This 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.
Check if I qualifyExtracted 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
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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