A Randomized Controlled Phase III Clinical 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
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.
• 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;
• Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
⁃ Organ function levels must meet the requirements;
⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and must be non-lactating; all enrolled patients must use adequate and highly effective contraceptive measures throughout the entire treatment period and for 7 months after treatment completion.