A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable … (NCT06343948) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer(PANKU-Breast01)
China383 participantsStarted 2024-04-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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;
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;