Randomized, Double-blind, Placebo-controlled, Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
• Patients who voluntarily participate in the study, completely understand the study, and voluntarily sign the informed consent form (ICF).
• Female, ≥ 18 and ≤ 75 years of age at the time of signing the ICF.
• ECOG（Eastern Cooperative Oncology Group） performance status 0 or 1.
• Life expectancy ≥ 3 months.
• Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies, with hormone receptor positive and human epidermal growth factor receptor 2 negative confirmed by tumor histopathology and molecular pathology.
• No previous systemetic therapy for locally advanced or metastatic diseases that cannot receive radical surgeries/other local therapies.
• At least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors.
• Postmenopausal or premenopausal/perimenopausal female patients. Premenopausal or perimenopausal women should consent to receive goserelin therapy during the study.
• Laboratory test results before randomization meet the relevant requirements for organ function.