A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody i… (NCT07729956) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)
China436 participantsStarted 2026-08
Plain-language summary
This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
. Female patients aged 18 to 75 years;
. Expected survival time ≥ 3 months;
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
. Pathologically confirmed recurrent or metastatic triple-negative breast cancer;
. Confirmed PD-L1 expression positivity by central laboratory testing;
. No prior systemic anti-tumor therapy in the advanced/recurrent or metastatic setting;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Agree to provide archived tumor tissue specimens (surgical specimens) or fresh tissue samples from primary or metastatic lesions obtained within 3 years;
Exclusion criteria
. Received surgery, radical radiotherapy, or immunotherapy within 4 weeks before the first dose;
. Prior exposure to ADC drugs with topoisomerase I inhibitor payload;
. Prior treatment with other T-cell receptor-targeting agents (excluding PD-1/PD-L1);
. Use of immunomodulators within 14 days before the first study drug dose;
. History of severe cardiac or cerebrovascular disease;
. Receiving chronic systemic corticosteroids at \>10 mg/day prednisone before the first dose;
. Active autoimmune or inflammatory disease;
. Any thrombotic event within 6 months before randomization;