Feasibility study of TC (docetaxel/cyclophosphamide) as neoadjuvant chemotherapy for primary breast cancer with negative HER2
Phase 2
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000007103
- Lead Sponsor
- Kyushu Breast Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
1. Bilateral breast cancer 2. Male breast cancer 3. With active another cancer 4. History of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix 5. History of hypersensitivity reaction to any drugs which are to be used in this study 6. Uncontrolled underlying medical conditions 7. Patients who need concurrent treatment by corticosteroids except for premedication 8. Severe psychiatric disorders 9. Pregnant or lactation women, or women with suspected pregnancy 10. Patients judged by the investigator to be unfit to be enrolled into the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Breast-conserving rate Pathological complete response rate Safety Disease free survival, Overall survival