Multicenter phase II trial to Prevent Docetaxel-Induced Nail change using a Frozen Glove with docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer: Tokai Breast Cancer Clinical Research Group (TBCRG) 03 trial

UMIN ID: UMIN000000806

Registered date:01/09/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 2007/07/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Frozen glove to prevent docetaxel-induced nail toxicities with right hand. Docetaxel 75 mg/m2 IV Day 1Cyclophosphamide 600 mg/m2 IV Day 1 Every 21 days X 4 CyclesUse standard premedication

Outcome(s)

• Primary Outcome: Prevention of nail change by frozen glove
• Secondary Outcome: Safety, feasibility

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude criteria: 1.As neoadjuvant and adjuvant therapy , treated hormone therapy and chemotherapy 2.HER2 / neu gene overexpressed or amplified 3.A history of whitlow and cold allergy 4.Bilateral breast cancer and Inflammatory breast cancer 5.Uncontrolled medical conditions 6.Hepatitis B 7.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 8.Sever infection 9.Peripheral neuropathy 10.Pleural or pericardial effusion requiring treatment 11.Pregnant or lactating women and women of child bearing potential not using contraception. 12.Grade2-4 Severe peripheral edema. 13.Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 14.A history of hypersensitivity reaction to drugs formulated with Polysorbate 80 15.Severe psychiatric disorders 16.Patients judged by the investigator to be unfit to be enrolled into the study

Related Information

• Primary Sponsor: Tokai Breast Cancer Clinical Research Group (TBCRG)
• Source(s) of Monetary Support: Public Health Research Foundation