EUCTR2013-002588-24-ES
Active, not recruiting
Not Applicable
A randomized pre-surgical pharmacodynamics study to assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer - MONALEESA1
ovartis Farmacéutica , S.A.0 sites120 target enrollmentOctober 1, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Farmacéutica , S.A.
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 11 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
Similar Trials
Recruiting
Phase 2
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)breast cancer10006291NL-OMON40407ovartis Pharma BV18
Active, not recruiting
Phase 1
A pharmacodynamics pre-surgical study of LEE011 in early breast cancer patientsHR+, HER2- early breast cancerTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-002588-24-FRovartis Pharma AG120
Active, not recruiting
Phase 1
A pharmacodynamics pre-surgical study of LEE011 in early breast cancer patientsEUCTR2013-002588-24-NLovartis Pharma AG14
Terminated
Phase 2
A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)Early Breast CancerNCT01919229Novartis Pharmaceuticals14
Completed
Phase 2
Celexib and Peregabalin effect on pain after Orthopedic surgery.The pain after Orthopedic surgeries..Other Complication of Orthopedic surgeries.IRCT2016012715281N5Vice chancellor for research, Shiraz University of Medical Sciences (International Branch)120