A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable ā¦ (NCT06382142) | Clinical Trial Compass
Active ā Not RecruitingPhase 3
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer(PANKU-Breast02)
China418 participantsStarted 2024-06-21
Plain-language 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Voluntarily sign the informed consent and follow the requirements of the protocol;
ā. No gender limit;
ā. Age ā„18 years old and ā¤75 years old;
ā. Expected survival time ā„3 months;
ā. Patients with unresectable, locally advanced or metastatic triple-negative breast cancer;
ā. Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
ā. The subjects had received 1-2 lines of chemotherapy regimens in the locally advanced or metastatic stage, and had been treated with taxanes previously;
ā. Acceptability of chemotherapy with eribulin, capecitabine, gemcitabine, or vinorelbine, as assessed by the investigator;
Exclusion criteria
ā. Prior receipt of an ADC with a TOPI inhibitor as a toxin;
ā. Prior receipt of an ADC or antibody drug targeting EGFR and/or HER3;
ā. 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;
ā. Anthracycline equivalent cumulative dose of adriamycin \> 360 mg/m2;