A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07518173
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BL-M07D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Pertuzumab — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Trastuzumab — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Docetaxel — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.

Study Details

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 combined with Pertuzumab versus docetaxel plus Trastuzumab and Pertuzumab in patients with first-line HER2-positive recurrent or metastatic breast cancer.

Key Dates

First listed
Apr 8, 2026
Start date
Apr 21, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
596 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BL-M07D1 + Pertuzumab
    Participants receive BL-M07D1 + Pertuzumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
  • Active Comparator: Docetaxel + Trastuzumab + Pertuzumab
    Participants receive Docetaxel + Trastuzumab + Pertuzumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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