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 (Jun 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
Treatments studied
Targeted therapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07008976 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received HER2-targeted therapy and taxane.
Does this trial require ERBB2?
Yes, ERBB2 overexpression or amplification is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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