A randomized pre-surgical pharmacodynamics study to assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer (CLEE011A 2201) - MONALEESA-1

ovartis Pharma BV0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•Female >= 18 years old, with newly diagnosed resectable grade II or grade III invasive breast cancer. No prior therapy for breast cancer.
•Postmenopausal. See protocol page 30 for details.
•Confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive HER2 negative breast cancer.
•Patient has a grade II or grade III invasive breast cancer
•Adequate bone marrow and organ function as defined by laboratory values (See
•protocol page 30 for details.
•At least one breast lesion with a diameter of >=1.0 cm by ultrasound, mammography, CT- scan, or MRI.
•ECOG performance status 0 or 1.

•Any prior therapy for breast cancer.
•Known history of HIV infection (testing not mandatory).
•Active cardiac disease or a history of cardiac dysfunction. See protocol page 31 for details.
•Systemic corticosteroids within 1 week prior to starting study drug. See protocol page 31 for exceptions.

发起方

ovartis Pharma BV