Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer

UMIN ID: UMIN000001583

Registered date:17/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 2008/08/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): As FEC regimen, 5-fluorouracil 500 mg/m2 iv, epirubicine 100 mg/m2 iv and cyclophophamide 500 mg/m2 iv every 3 weeks, repeated 4 cycles Docetaxel 75 mg/m2 iv every 3 weeks, repeated 4 cycles following FEC. Trastuzumab beginning with a loading dose of 8 mg/kg of body weight, iv given with the first dose of Docetaxel and followed by does of 6 mg/kg iv every 3 weeks, repeated 4 cycles. Total duration of trastuzumab will be 1 year.

Outcome(s)

• Primary Outcome: Completion rate of the treatment according with the protocol
• Secondary Outcome: Safety Postponement rate as compared to planned treatment schedule Dose reduction rate as compared to planned doses of chemotherapeutic agents

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Kyushu Breast Cancer Study Group
• Source(s) of Monetary Support: Non-profit Organization Clinical Hematology/Oncology Study Group