Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer
Not Applicable
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000001583
- Lead Sponsor
- Kyushu Breast Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1. Clinical or radiological evidence of metastatic breast cancer 2. complication of the active other malignancies 3. Serious cardiac disfunction 4. Uncontrolled medical conditions 5. Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 6. Patients who are required concurrent treatment by corticosteroids except for premedication 7 .Severe psychiatric disorders 8. Pregnant or lactation women, or women with suspected pregnancy 9. History of hypersensitivity reaction to drug formulated with Polysorbate 80 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 Completion rate of the treatment according with the protocol
- Secondary Outcome Measures
Name Time Method Safety Postponement rate as compared to planned treatment schedule Dose reduction rate as compared to planned doses of chemotherapeutic agents