Randomized phase II study of neoadjuvant chemotherapy with or without letrozole for postmenopausal ER-positive/HER2-negative breast cancers
- Conditions
- Postmenopausal breast cancer
- Registration Number
- JPRN-UMIN000008416
- Lead Sponsor
- Kobe Breast Cancer Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 70
Not provided
1) Inflammatory breast cancer 2) Bilateral breast cancers without DCIS or ICIS 3) With multiple cancers diagnosed with 5 years 4) With uncontrollable hypertension, angina pectoris, congestive heart failure 5) With severe complication including infection or uncontrolled diabetes mellitus 6) With viral hepatitis (HBs antigen- or HCV antibody-positive) 7) Patients treated with endocrine therapy 8) Infection or possible infection associated with clinical symptoms such as fever 9) With severe edema 10) With severe mental disorder 11) Cases who physician judged improper to entry this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Response Rate
- Secondary Outcome Measures
Name Time Method Pathological complete response rate, Breast conserving rate, Safety, Disease-free survival, Overall survival