a study comparing bl-b01d1 with chemotherapy of physician's choice in patients with unresectable locally advanced, recurrent, or metastatic hr+her2- breast cancer

Conditions: HR+HER2- Breast Cancer

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.


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; 4. expected survival time ≥3 months; 5. patients with unresectable locally advanced, recurrent metastatic hr+her2- breast cancer; 6. 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; 7. documented radiographic disease progression; 8. consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years; 9. must have at least one measurable lesion according to recist v1.1 definition; 10. ecog score 0 or 1; 11. toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by nci-ctcae v5.0; 12. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 13. no blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements; 14. urine protein ≤2+ or \< 1000mg/24h; 15. 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 it 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 drug with a topoisomerase i inhibitor as a toxin; 2. prior receipt of an adc or antibody drug targeting egfr and/or her3; 3. 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; 4. anthracycline equivalent cumulative dose of adriamycin \> 360 mg/m2; 5. history of severe cardiovascular or cerebrovascular disease; 6. unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening; infusion-related thrombosis was excluded; 7. qt prolongation, complete left bundle branch block, iii degree atrioventricular block, frequent and uncontrollable arrhythmia; 8. other malignant tumors diagnosed within 3 years before the first dose; 9. hypertension poorly controlled by two antihypertensive drugs; patients with poor glycemic control; 10. 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; 11. complicated pulmonary diseases leading to clinically severe respiratory function impairment; 12. patients with active central nervous system metastases; 13. patients with massive or symptomatic effusions or poorly controlled effusions; 14. imaging examination showed that the tumor had invaded or wrapped around the large blood vessels in the abdomen, chest, neck, and pharynx; 15. severe infection within 4 weeks before randomization; evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization; 16. was receiving \&gt before randomization; long-term systemic corticosteroid therapy with 10mg/ day prednisone or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy; 17. severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 18. subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 19. patients with inflammatory bowel disease, extensive bowel resection history, immune enteritis history, intestinal obstruction or chronic diarrhea; 20. have a history of allergy to recombinant humanized antibodies or to bl-b01d1 and any excipients; a history of autologous or allogeneic stem cell transplantation; 21. human immunodeficiency virus antibody positive, active hepatitis b virus infection or hepatitis c virus infection; 22. a history of severe neurological or psychiatric illness; 23. received other unmarketed investigational drug or treatment within 4 weeks before the first dose; a live vaccine dose within 28 days before the planned dose or the first dose; 24. any complications or other circumstances deemed by the investigator to preclude participation in the trial.