Phase II study of efficacy of letrozole in postmenopausal patients with endocrine-responsive, HER2-negative metastatic breast cancer resistant to exemestane or anastrozole.
- Conditions
- Metastatic breast cancer
- Registration Number
- JPRN-UMIN000006667
- Lead Sponsor
- Setouchi Breast Comprehensive Support Organaization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
Not provided
1. Patients with active other malignancies.(other simultaneity malignancies and other heterochrony malignancies within 5 years disease-free interval) *Except patients who cured carcinoma in situ or intramucosal carcinoma by local treatment. 2. Patients with brain metastasis with symptom. 3. Patients who confirmed to be unstable angina pectoris, congestive heart failure, myocardial infarction, myocardial infarction, ventricular arrhythmia that need treat within 6 months before register. 4. Patients who confirmed to be uncontrollable hypertension, diabetes when you register. 5. Patients with severe infectious disease. 6. Patients with severe complications 7. Patients who are receiving bisphosphonates for hypercalcemia by malignancy.(Except patients who had receiving bisphosphonates for osteoporosis, bone metastases.) 8. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical benefit rate
- Secondary Outcome Measures
Name Time Method Response rate, Time to progression, Overall survival, Safety