EUCTR2013-002588-24-FR
Active, not recruiting
Phase 1
A randomized pre-surgical pharmacodynamics study to assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer
DrugsLETROZOL ACCORD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HR+, HER2- early breast cancer
- Sponsor
- ovartis Pharma AG
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 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.
Exclusion Criteria
- •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 or
- •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
Outcomes
Primary Outcomes
Not specified
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