Phase II study of neoadjuvant Letrozole combined with low dose metronomic Cyclophosphamide for postmenopausal women with Endocrine-responsive Breast Cancer (JBCRG-07)
- Conditions
- Postmenopausal, hormone-receptor positive and primary breast cancer
- Registration Number
- JPRN-UMIN000001331
- Lead Sponsor
- Japan Breast Cancer Research Group (JBCRG)
- Brief Summary
Results: The CRR was 67.5% '52.0-80.0%). No patients achieved pCR. Seven patients (17.5%) showed grade 2 pathological responses and 28 (70%) showed grade 1 responses. Conclusion: Metronomic chemo-endocrine therapy with letrozole plus cyclophosphamide showed a good response and was tolerated in Japanese postmenopausal patients with ER-positive breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 41
Not provided
1. Prior chemotherapy or endocrine therapy 2. Under treatment by medicines with the possibility to affect the state of the sex hormone (hormone replacement therapy or raloxifene, etc) 3. Active double cancer 4. Inflammatory breast cancer 5. Bilateral breast cancer 6. History of drug-hypersensitivity 7. Under treatment of investigational new drug for other disease except breast cancer 8. Mental disease 9. Patient judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Pathological CR rate, Breast Conserving Surgery rate, Safety, Disease- free survival and Overall survival