A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 with or without Pertuzumab in the neoadjuvant treatment of HER2-positive breast cancer. The study is divided into a single-arm study phase (Phase II) and a randomized controlled study phase (Phase III).

Trial Details

NCT ID
NCT06891833
Phase
PHASE2 / PHASE3
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • BL-M07D1
  • Pertuzumab
Locations (sample)
  • Bengbu, Anhui, China|32.94083,117.36083
  • Hefei, Anhui, China|31.86389,117.28083
  • Hefei, Anhui, China|31.86389,117.28083
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Fuzhou, Fujian, China|26.06139,119.30611

Key Eligibility Criteria

  • Voluntarily signed informed consent and followed the program requirements;
  • Females ≥18 and ≤75 years of age at the time of signing the informed consent;
  • Expected survival time ≥6 months;
  • Patients with HER2-positive invasive breast cancer confirmed by histologic examination;

For full eligibility, visit ClinicalTrials.gov.

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