A Phase II study of docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer

UMIN ID: UMIN000000493

Registered date:01/10/2006

Basic Information

• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 2006/10/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Docetaxel 75 mg/m2 IV Day 1 Cyclophosphamide 600 mg/m2 IV Day 1 Every 21 days X 4 Cycles Use standard premedication

Outcome(s)

• Primary Outcome: Safety, feasibility

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude criteria: Male A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix Bilateral breast cancer Inflammatory breast cancer A history of hypersensitivity reaction to drugs formulated with Polysorbate 80 Uncontrolled medical conditions (e.g., malignant hypertension, congestive heart failure, renal failure, myocardial infarction in the previous 6 months, treatment required arrhythmia, infection, hemorrhage) Grade 2-4 peripheral neuropathy Pleural or pericardial effusion requiring treatment Severe peripheral edema. Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray Patients who require concurrent treatment by corticosteroids except for premedication. Evere psychiatric disorders Pregnant or lactating women Patients judged by the investigator to be unfit to be enrolled into the study Prior chemotherapy or radiation therapy for other cancer within 3 years including neo-adjuvant chemotherapy for locally advanced breast cancer.

Related Information

• Primary Sponsor: Japan East Cancer Center Breast Cancer Consortium
• Source(s) of Monetary Support: Advanced Clinical Research Organization