CT7001_002 (SUMIT-BC) - An open-label Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant with or without Samuraciclib in Participants with Metastatic or Locally Advanced Hormone Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

Carrick Therapeutics Limited0 个研究点目标入组 60 人开始时间: 2023年6月1日最近更新: 2024年7月22日

适应症

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•Histologically confirmed diagnosis of BC. Evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent and having the following specifics: estrogen receptor positive with or without progesterone receptor positive tumor; HER2-negative., Documented objective disease progression while on or within 6 months after the end of the most recent therapy., Received prior AI in combination with a CDK4/6i in the following settings: locally advanced or metastatic, or adjuvant., Known TP53 mutation status., Participants must have measurable disease or bone only disease (which can be measurable or non-measurable) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention., Eastern Cooperative Oncology Group (ECOG) performance status =1 with no deterioration over the past 2 weeks., Expected life expectancy of >12 weeks in the judgement of the treating investigator.

•Inflammatory BC., Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix., Prior treatment with: a selective estrogen receptor degrader (SERD) or similar agents in the advanced/metastatic setting; more than 1 line of endocrine treatment for locally advanced or metastatic disease treatment., Inadequate hepatic, renal, and bone marrow function., Clinically significant cardiovascular disease., Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease., Pregnant or breastfeeding women.

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