A Randomized Controlled Phase Ill Clinical Study of BL-M07D1 for Injection Versus Trastuzumab Emtansine (T-DM1) in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Sign the informed consent form voluntarily and follow the protocol requirements;

• Women aged ≥18 years and ≤75 years at the time of written informed consent;

• Expected survival time ≥6 months;

• Patients with histologically confirmed HER2-positive invasive breast cancer;

• Before neoadjuvant therapy, the clinical TNM staging was T1-4, N0-3, M0 (excluding T1N0) based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging system;

• The presence of residual invasive cancer confirmed by postoperative pathological examination must meet one of the conditions specified in the protocol;

• Previous neoadjuvant therapy should meet the prescribed treatment conditions;

• Had received radical mastectomy;

• Determine hormone receptor (HR) status;

⁃ The interval between radical surgery and randomization was at least 3 weeks and at most 12 weeks;

⁃ ECOG score 0 or 1;

⁃ The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;

⁃ No blood transfusion within 14 days before the first use of the study drug and no use of colony-stimulating factors were allowed;

⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients should use adequate and highly effective contraception during the entire treatment cycle and for 7 months after the end of treatment.

Locations
Other Locations
China
Jiangsu Province Hospital
RECRUITING
Nanjing
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
15013238943
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2031-12
Participants
Target number of participants: 1450
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov