A Randomized Controlled Phase III Clinical Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- BL-M07D1
- Conditions
- HER2-positive Breast Cancer
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 274
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had failed previous treatment with taxanes and trastuzumab.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily sign the informed consent and follow the requirements of the protocol;
- •No gender limit;
- •Age ≥18 years old and ≤75 years old at the time of signing the informed consent;
- •expected survival time ≥3 months;
- •Patients with histologically or cytologically confirmed, unresectable, locally advanced or metastatic HER2-positive breast cancer;
- •Provide the latest tumor tissues to the central laboratory for HER2 and HR detection;
- •Must have at least one measurable target lesion that meets the RECIST v1.1 definition;
- •ECOG 0 or 1;
- •Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
Exclusion Criteria
- •Received chemotherapy with mitomycin C and nitrosourea within 6 weeks before the first dose, received surgery, chemotherapy, immunotherapy, etc. Within 4 weeks before the first dose, received endocrine therapy, palliative radiotherapy, and anti-tumor therapy approved by NMPA within 2 weeks before the first dose;
- •Previous use of HER2-ADC in the metastatic background;
- •Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin;
- •The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
- •Complicated with pulmonary diseases leading to severe impairment of lung function;
- •History of ILD/interstitial pneumonia, current ILD/interstitial pneumonia, or suspected ILD/interstitial pneumonia; According to CTCAE v5.0 was defined as ≥ grade 3 pulmonary disease and ≥ grade 2 radiation pneumonitis;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Other primary malignancies diagnosed within 5 years before the first dose;
- •Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
- •Patients with active central nervous system metastases;
Arms & Interventions
Experimental Group
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.
Intervention: BL-M07D1
Control group
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.
Intervention: T-DM1
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: Up to approximately 24 months
Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Secondary Outcomes
- Duration of Response (DOR)(Up to approximately 24 months)
- Objective Response Rate (ORR)(Up to approximately 24 months)
- Overall survival (OS)(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)