A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer After Taxane Failure
Overview
- Phase
- Phase 3
- Intervention
- Gemcitabine
- Conditions
- Triple-Negative Breast Cancer
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 418
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
- Status
- Active, not recruiting
- Last Updated
- 12 days ago
Overview
Brief Summary
This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced or metastatic Triple-Negative breast cancer after taxane failure.
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;
- •Expected survival time ≥3 months;
- •Patients with unresectable, locally advanced or metastatic triple-negative breast cancer;
- •Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
- •The subjects had received 1-2 lines of chemotherapy regimens in the locally advanced or metastatic stage, and had been treated with taxanes previously;
- •Acceptability of chemotherapy with eribulin, capecitabine, gemcitabine, or vinorelbine, as assessed by the investigator;
- •Patients with baseline brain metastases should have received treatment for all brain metastases and be stable;
- •Must have at least one measurable lesion that meets the RECIST v1.1 definition;
Exclusion Criteria
- •Prior receipt of an ADC with a TOPI inhibitor as a toxin;
- •Prior receipt of an ADC or antibody drug targeting EGFR and/or HER3;
- •Chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy within 5 days, palliative radiotherapy and anti-tumor therapy within 2 weeks;
- •Anthracycline equivalent cumulative dose of adriamycin \> 360 mg/m2;
- •History of severe cardiovascular or cerebrovascular disease;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Active malignancy diagnosed within 5 years before randomization;
- •Hypertension poorly controlled by two antihypertensive drugs;
- •Patients with poor blood glucose control before the first dose;
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: 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
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
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.
Overall survival (OS)
Time Frame: Up to approximately 24 months
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Secondary Outcomes
- 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)