a study comparing bl-b01d1 with chemotherapy of physician's choice in patients with unresectable locally advanced or metastatic triple-negative breast cancer

Conditions: Triple-Negative Breast Cancer

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.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent and follow the requirements of the protocol; 2. no gender limit; 3. age ≥18 years old and ≤75 years old; 4. expected survival time ≥3 months; 5. patients with unresectable, locally advanced or metastatic triple-negative breast cancer; 6. consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years; 7. the subjects had received 1-2 lines of chemotherapy regimens in the locally advanced or metastatic stage, and had been treated with taxanes previously; 8. acceptability of chemotherapy with eribulin, capecitabine, gemcitabine, or vinorelbine, as assessed by the investigator; 9. patients with baseline brain metastases should have received treatment for all brain metastases and be stable; 10. must have at least one measurable lesion that meets the recist v1.1 definition; 11. ecog score 0 or 1; 12. toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by nci-ctcae v5.0; 13. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 14. no blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before the first use of the study drug, and the organ function level must meet the requirements; 15. coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5×uln; 16. urine protein ≤2+ or \< 1000mg/24h; 17. for premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; all enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment. exclusion criteria: 1. prior receipt of an adc with a topi inhibitor as a toxin; 2. prior receipt of an adc or antibody drug targeting egfr and/or her3; 3. 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; 4. anthracycline equivalent cumulative dose of adriamycin \> 360 mg/m2; 5. history of severe cardiovascular or cerebrovascular disease; 6. unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 7. qt prolongation, complete left bundle branch block, iii degree atrioventricular block, frequent and uncontrollable arrhythmia; 8. active malignancy diagnosed within 5 years before randomization; 9. hypertension poorly controlled by two antihypertensive drugs; 10. patients with poor blood glucose control before the first dose; 11. a history of interstitial lung disease requiring steroid therapy, or current radiation pneumonitis, or a suspicion of such disease; 12. complicated with pulmonary diseases leading to clinically severe respiratory impairment; 13. patients with carcinomatous meningitis (meningeal metastasis) or brain stem metastasis or spinal cord compression; 14. have a history of allergy to recombinant humanized antibodies or any of the ingredients of bl-b01d1; 15. a history of autologous or allogeneic stem cell transplantation; 16. human immunodeficiency virus antibody positive, active hepatitis b virus infection, or hepatitis c virus infection; 17. severe infection within 4 weeks before randomization; evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization; 18. patients with massive or symptomatic effusions or poorly controlled effusions; 19. imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx; 20. were receiving long-term systemic corticosteroids or equivalent active anti-inflammatory drugs or any form of immunosuppressive therapy before randomization; 21. received other unmarketed investigational drug or treatment within 4 weeks before the first dose; 22. patients with superior vena cava syndrome should not be rehydrated; 23. a history of severe neurological or mental illness; 24. severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 25. subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 26. history of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection or presence of crohn's disease, ulcerative colitis, or chronic diarrhea; 27. patients scheduled for vaccination or receiving live vaccine within 28 days before the first dose; 28. other circumstances that were assessed by the investigator as inappropriate for participation in the trial.