Phase II study of combination chemotherapy with mitomycin and methotrexate for triple negative breast cancer
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000003512
- Lead Sponsor
- Cancer Institute Hospital, Japanese Foundation for Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
Non invasive or microinvasive breast cancer Previously treated with chemotherapy, hormone therapy or radiotherapy Serious complication (infection, cardiac disease, pulmonary fibrosis interstitial pneumonitis, bleeding) Hepatitis type B and its carrier Pregnant, nursing or willing to be pregnant Inadequate to entry judged by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate by combination chemotherapy with mitomycin and methotrexate for triple negative breast cancer
- Secondary Outcome Measures
Name Time Method Metastatic breast cancer: progression free survival, time to treatment failure, overall survival, adverse events Locally advanced disease: pathological response rate, pathological complete response rate, clinical response rate, breast conserving rate, disappearance rate of axillary node metastasis, distant-metastasis free survival, disease free survival, overall survival, adverse events