A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer - CLEE011X2107

ovartis Pharma AG0 个研究点目标入组 251 人开始时间: 2024年4月9日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Adult women (age =18 years) with advanced (metastatic or locally advanced) breast cancer not amenable to curative treatment by surgery or radiotherapy., Histologic or cytologic confirmation of hormone-receptor positive (ER+ and/or PR+) breast cancer, Postmenopausal women, Dose Escalation: Any number of prior lines of endocrine therapy is allowed with up to one prior cytotoxic regimen in the advanced (metastatic or locally advanced) setting., Dose Expansion Arm 1, 2 and 3: No prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole or anastrozole for a maximum duration of one month., Dose Expansion Arms 2 and 3 and Dose Escalation Arm 4: Patient has known PIK3CA status (mutated or non-mutated), Dose Escalation: Presence of measurable or non-measurable disease (as defined by RECIST 1.1 criteria)., Dose Expansion: At least one measurable lesion, or lytic or mixed bone lesions in the absence of measurable disease (as defined by RECIST 1.1) for Arm 1 to Arm 3

•HER2-overexpression in the patient’s tumor tissue by local laboratory testing (IHC 3+ or in situ hybridization positive)., Patients with active CNS or other brain metastases. Patients with asymptomatic brain metastases that have been adequately treated and do not require corticosteroid therapy and /or enzyme inducing anti–epileptic medication for brain metastases are eligible., Major surgery within 2 weeks, Acute or chronic pancreatitis, Bilateral diffuse lymphangitic carcinomatosis, Another malignancy within 3 years, Receiving hormone replacement therapy that cannot be discontinued, Impaired cardiac function, Patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose = 126 mg/dL / 7.0 mmol/L or hemoglobin A1c >6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.

发起方