A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurre… (NCT07678957) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer
China120 participantsStarted 2026-07
Plain-language summary
This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing 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 years and ≤75 years at the time of signing the informed consent form；
. Life expectancy ≥12 weeks；
. Locally recurrent or metastatic breast cancer that is hormone receptor (HR)-positive and HER2-low expressing；
. Provide adequate and recent tumor tissue specimens for central laboratory testing of HER2, HR, and other biomarkers as required；
. Meet the prior treatment requirements as specified in the protocol；
. Have at least one measurable target lesion per RECIST v1.1 criteria；
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
Exclusion criteria
. Received surgery, curative radiotherapy, immunotherapy, or other systemic anti-tumor therapies within 4 weeks prior to the first dose;
. Intolerance to the control drug or presence of other contraindications to the control drug;
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.