A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT06830889
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.
  • T-DM1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.

Study Details

This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in the adjuvant treatment of HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy.

Key Dates

First listed
Feb 17, 2025
Start date
Jun 3, 2025
Status verified
Jan 2026
Primary completion
Oct 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
1,450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BL-M07D1
    Participants receive BL-M07D1 as intravenous infusion for 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: T-DM1
    Participants receive T-DM1 as intravenous infusion for 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

Invasive Disease-free Survival (IDFS) [ Time Frame: Up to approximately 77 months ]

Central Contacts

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