A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer

This study is designed to compare efficacy and safety of GQ1005 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.

Trial Details

NCT ID
NCT07673029
Phase
PHASE3
Sponsor
GeneQuantum Healthcare (Suzhou) Co., Ltd.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • GQ1005
  • T-DM1
Locations (sample)
  • Bengbu, Anhui, China|32.94083,117.36083
  • Hefei, Anhui, China|31.86389,117.28083
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Fuzhou, Fujian, China|26.06139,119.30611

Key Eligibility Criteria

  • Male or female adults ≥ 18 years at the time of voluntary signing of informed consent.
  • Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane
  • Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
  • Presence of at least one measurable lesion according to RECIST v1.1

For full eligibility, visit ClinicalTrials.gov.

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