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

ovartis Pharma AG0 sites14 target enrollmentAugust 30, 2013

Overview

No summary available.

Registry

who.int

Start Date

August 30, 2013

End Date

September 10, 2014

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•1\. Female patient is \= 18 years old at the time of informed consent, with newly
•diagnosed resectable breast cancer, who received no prior therapy for
•breast cancer.
•2\. Patient is postmenopausal. Postmenopausal status is defined either
•Prior bilateral oophorectomy
•Age \<60 and amenorrhea for 12 or more months and FSH and
•estradiol in the postmenopausal range.
•3\. Patient has a histologically (and/or cytologically) confirmed diagnosis
•of estrogen\-receptor positive and/or progesterone receptor positive
•breast cancer by local laboratory.

•1\. Patient has received any prior therapy for breast cancer.
•2\. Patient has a concurrent malignancy or malignancy within 3 years of
•randomization, with the exception of adequately treated, basal cell skin cancer,
•squamous cell carcinoma, non\-melanomatous skin cancer or
•curatively resected cervical cancer.
•3\. Patient has active cardiac disease or a history of cardiac dysfunction
•including any of the following:
•History of angina pectoris, symptomatic pericarditis, or myocardial
•infarction within 12 months prior to study entry
•History of documented congestive heart failure (New York Heart