A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer After Failure of at Least One Prior Line of Chemotherapy
Overview
- Phase
- Phase 3
- Intervention
- Eribulin
- Conditions
- HR+HER2- Breast Cancer
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 383
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
- Status
- Active, not recruiting
- Last Updated
- 15 days ago
Overview
Brief Summary
This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+HER2- breast cancer after failure of at least one prior line of chemotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily sign the informed consent and follow the requirements of the protocol;
- •No gender limit;
- •Age ≥18 years old;
- •expected survival time ≥3 months;
- •Patients with unresectable locally advanced, recurrent metastatic HR+HER2- breast cancer;
- •The subjects had received 1-2 lines of chemotherapy regimens in the unresectable locally advanced recurrence or metastasis stage, and had been treated with endocrine, CDK4/6 inhibitors, and taxanes;
- •Documented radiographic disease progression;
- •Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
- •Must have at least one measurable lesion according to RECIST v1.1 definition;
- •ECOG score 0 or 1;
Exclusion Criteria
- •Prior receipt of an ADC drug with a topoisomerase I inhibitor as a toxin;
- •Prior receipt of an ADC or antibody drug targeting EGFR and/or HER3;
- •Chemotherapy, biological therapy, immunotherapy, etc., have been used within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy has been used within 5 days, palliative radiotherapy, modern Chinese medicine preparations approved by NMPA for anti-tumor therapy, etc., have been used within 2 weeks;
- •anthracycline equivalent cumulative dose of adriamycin \> 360 mg/m2;
- •History of severe cardiovascular or cerebrovascular disease;
- •Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening; Infusion-related thrombosis was excluded;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Other malignant tumors diagnosed within 3 years before the first dose;
- •Hypertension poorly controlled by two antihypertensive drugs; Patients with poor glycemic control;
- •A history of interstitial lung disease (ILD) requiring steroid therapy, current ILD or grade ≥2 radiation pneumonitis, or suspicion of such disease on imaging during screening;
Arms & Interventions
Eribulin or Vinorelbine or Gemcitabine or Capecitabine
Participants receive Eribulin or Vinorelbine or Gemcitabine or Capecitabine 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.
Intervention: Eribulin
Eribulin or Vinorelbine or Gemcitabine or Capecitabine
Participants receive Eribulin or Vinorelbine or Gemcitabine or Capecitabine 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.
Intervention: Gemcitabine
Eribulin or Vinorelbine or Gemcitabine or Capecitabine
Participants receive Eribulin or Vinorelbine or Gemcitabine or Capecitabine 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.
Intervention: Capecitabine
BL-B01D1
Participants receive BL-B01D1 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-B01D1
Eribulin or Vinorelbine or Gemcitabine or Capecitabine
Participants receive Eribulin or Vinorelbine or Gemcitabine or Capecitabine 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.
Intervention: Vinorelbine
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 are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Secondary Outcomes
- Overall survival (OS)(Up to approximately 24 months)
- Objective Response Rate (ORR)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)