a study comparing bl-m07d1 with t-dm1 in patients with unresectable locally advanced or metastatic her2-positive breast cancer

Conditions: HER2-positive Breast Cancer

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.


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 at the time of signing the informed consent; 4. expected survival time ≥3 months; 5. patients with histologically or cytologically confirmed, unresectable, locally advanced or metastatic her2-positive breast cancer; 6. provide the latest tumor tissues to the central laboratory for her2 and hr detection; 7. must have at least one measurable target lesion that meets the recist v1.1 definition; 8. ecog 0 or 1; 9. toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by nci-ctcae v5.0; 10. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. blood transfusion is not allowed within 14 days before the first use of the study drug, and no cell growth factor is allowed; 12. coagulation function: international normalized ratio (inr) ≤1.5 and activated partial thromboplastin time (aptt)≤1.5×uln; 13. urine protein ≤2+ or \< 1000mg/24h; 14. 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 7 months after the end of treatment. exclusion criteria: 1. 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; 2. previous use of her2-adc in the metastatic background; 3. prior treatment with an adc drug containing a camptothecin derivative (topoisomerase i inhibitor) as a toxin; 4. the history of severe cardiovascular and cerebrovascular diseases in the past six months was screened; 5. complicated with pulmonary diseases leading to severe impairment of lung function; 6. 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; 7. qt prolongation, complete left bundle branch block, iii degree atrioventricular block, frequent and uncontrollable arrhythmia; 8. other primary malignancies diagnosed within 5 years before the first dose; 9. poorly controlled hypertension (systolic blood pressure \&gt; 150 mmhg or diastolic blood pressure \&gt; 100 mmhg); 10. patients with active central nervous system metastases; 11. patients with a history of allergy to recombinant humanized antibody or to any of the excipents of bl-m07d1; 12. patients with known hypersensitivity or delayed hypersensitivity to certain components of t-dm1 or similar drugs, or known contraindications to t-dm1; 13. history of autologous or allogeneic stem cell transplantation or organ transplantation; 14. anthracycline-equivalent cumulative dose of adriamycin \> 360 mg/m2; 15. human immunodeficiency virus antibody positive, active hepatitis b virus infection, cirrhosis, or hepatitis c virus infection; 16. serious infection within 4 weeks before the first dose of study drug; there was active pulmonary inflammation at the time of screening; 17. patients with massive or symptomatic effusions or poorly controlled effusions; 18. receiving active antiinflammatory drugs or any form of immunosuppressive therapy before randomization; 19. a history of severe neurological or psychiatric illness; 20. subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 21. intestinal obstruction, crohn's disease, ulcerative colitis or chronic diarrhea; 22. subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose; 23. patients who were deemed by the investigator to be ineligible for the study.