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

NCT06830889 | Recruiting Phase 3 DMC

• 1 other identifier: BL-M07D1-302
• Study Type: interventional
• Target: 1,450
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HER2-positive Breast Cancer

Keywords

HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Invasive Disease-free Survival (IDFS)

  IDFS refers to the absence of invasive cancer recurrence after breast cancer treatment.

  Up to approximately 77 months

Secondary Outcomes (4)

• Disease-free Survival(DFS)

  Up to approximately 77 months

• Distant Recurrence-free Interval (DRFI)

  Up to approximately 77 months

• Overall Survival (OS)

  Up to approximately 77 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 77 months

Study Arms (2)

BL-M07D1

EXPERIMENTAL

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.

Drug: BL-M07D1

T-DM1

ACTIVE COMPARATOR

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.

Drug: T-DM1

Interventions

BL-M07D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1

T-DM1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

T-DM1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• A diagnosis of stage IV metastatic breast cancer was made;
• Bilateral breast cancer;
• Any previous history of breast cancer (unilateral or contralateral) except for lobular carcinoma in situ (LCIS);
• Evidence of clinically significant residual disease or recurrent or metastatic disease after neoadjuvant therapy and surgery;
• Other primary malignancies diagnosed within 5 years before the first dose;
• Received previous HER2-ADC, immunotherapy, or other antitumor biological therapy;
• Subjects are participating in other clinical studies and receiving anti-tumor treatment;
• Prior treatment with anthracyclines, doxorubicin equivalent cumulative dose \> 240 mg/m2; Cumulative dose of epirubicin or liposomal doxorubicin hydrochloride \> 480 mg/m2;
• History of severe cardiovascular or cerebrovascular disease within six months before screening;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
• Complicated with pulmonary diseases leading to severe impairment of lung function;
• A history of ILD/interstitial pneumonia requiring steroid therapy, current ILD/interstitial pneumonia, or suspected such disease during screening; CTCAE v5.0 was used to define grade ≥3 pulmonary disease and grade ≥2 radiation pneumonitis;
• Human immunodeficiency virus antibody (HIVAb) positive, active hepatitis B virus infection, liver cirrhosis, or hepatitis C virus infection;
• Had a serious infection within 4 weeks before the first dose of study drug; There was active pulmonary inflammation at the time of screening;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 17, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

CN (2)