A PHASE III TRIAL EVALUATING THE ROLE OF CONTINOUS LETROZOLE VERSUS INTERMITTENT LETROZOLE FOLLOWING 4 TO 6 YEARS OF PRIOR ADJUVANT ENDOCRINE THERAPY FOR POSTMENOPAUSAL WOMEN WITH HORMONE-RECEPTOR POSITIVE, NODE POSITIVE EARLY STAGE BREAST CANCER - SOLE
- Conditions
- BREAST CANCERMedDRA version: 14.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2007-001370-88-IT
- Lead Sponsor
- IBCSG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 4884
Postmenopausal patients with oparable breast cancer. Disease free patients at the time of randomization - Diagnosis of hormone receptor positive breast cancer (ER and/or PgR > 10%), node positive - Patients who completed a 4-6 year adjuvant treatment with SERMs and or aromatase inhibitors- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-Pre menopausal patients - Breast inflammatory cancer - Sovraclavear node involvement- Bilateral breast cancer- Bone fracture due to osteoporosis during the 4-6 years hormonal treatment - Patients with previous diagnosis of controlateral or ipsilateral breast cancer
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method