Randomized Phase III Study of Adjuvant Endocrine-Therapy with or without Chemotherapy for Postmenopausal Breast Cancer Patients who Responded to Neoadjuvant Letrozole
Phase 3
- Conditions
- postmenopausal primary breast cancer
- Registration Number
- JPRN-UMIN000001090
- Lead Sponsor
- EOS executive committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 850
Inclusion Criteria
Not provided
Exclusion Criteria
1. Positive sentinel lymph nodes before the registration. 2. Synchronous or asynchronous bilateral breast cancer. 3. Multifocal breast cancer of plural region 4. Double invasive carcinoma (in less than 5 years after the last treatment). 5. History of breast cancer. 6. Under treatment with continuous systemic steroid, estrogen or SERM. 7. Active participant in any other clinical trial for breast cancer. 8. Patient judged inappropriate for this study by the physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-Free Survival(DFS)
- Secondary Outcome Measures
Name Time Method Overall Survival(OS), Clinical response rate for neoadjuvant letrozole, Pathological response, Breast-conserving surgery rate, DFS and OS by the clinical response (CR / PR / SD / PD) of neoadjuvant letrozol, Safety, HRQOL, Cost-Effectiveness(QALY)