A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in … (NCT07518173) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer
China596 participantsStarted 2026-04
Plain-language summary
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 combined with Pertuzumab versus docetaxel plus Trastuzumab and Pertuzumab in patients with first-line HER2-positive recurrent or metastatic breast cancer.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Voluntarily sign the informed consent form and comply with the protocol requirements;
✓. Female patients aged ≥18 and ≤75 years at the time of signing the informed consent form;
✓. Expected survival time ≥12 weeks;
✓. Patients with histologically or cytologically confirmed, previously untreated, unresectable recurrent or metastatic HER2-positive breast cancer;
✓. Clear hormone receptor (HR) status;
✓. Agree to provide eligible tumor tissue specimens;
✓. Have at least one measurable target lesion as defined by RECIST v1.1;
✓. ECOG performance status score of 0 or 1;
Exclusion criteria
✕. Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose.
✕. Previously received ADC drug therapy with camptothecin derivatives as toxins.
✕. History of severe cardiovascular or cerebrovascular disease within six months before screening.
✕. Concomitant pulmonary disease resulting in severely impaired lung function.
✕. History of interstitial lung disease (ILD)/interstitial pneumonia requiring corticosteroid therapy, etc.