Feasibility study of TC(docetaxel+Cyclophosphamide)as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor(KBC-SG 0803)

UMIN ID: UMIN000001582

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: 102
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 4 cycles of TC (Docetaxel 75 mg/m2 / Cyclophosphamide 600mg/m2), every 3 weeks

Outcome(s)

• Primary Outcome: completion rate
• Secondary Outcome: safety, disease-free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude criteria: 1.History of bilateral breast cancer 2.History of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix 3.Inflammatory breast cancer 4.Male 5.A history of hypersensitivity reaction to any drugs. 6.Uncontrolled medical conditions. 7.Suspected of infection with fever 8.Severe peripheral neuropathy (>grade 1) 9.Symptomatic varicella. 10.HBs antigen positive 11.Treatment required pleural or pericardial effusions 12.Severe peripheral edema (>grade 1) 13.Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 14.Patients who are required concurrent treatment by corticosteroids except for premedication 15.Severe psychiatric disorders 16.Pregnant or lactation women, or women with suspected pregnancy 17.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 Henmatology/Oncology Study Group