Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) (OOTR N003)

UMIN ID: C000000322

Registered date:10/02/2006

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Operable breast cancer
• Date of first enrollment: 2005/12/01
• Target sample size: 500
• Countries of recruitment: Japan,Asia(except Japan)
• Study type: Interventional

Intervention(s)

5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by docetaxel (T)
5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by docetaxel, capecitabine (TX)

Outcome(s)

• Primary Outcome: Pathologic response (pCR rate)
• Secondary Outcome: Toxicity Clinical response Frequency of breast conservation surgery Frequency of axillary lymph node conservation surgery Disease-free survival Overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude criteria: Male History of drug hypersensitivity Uncontrolled medical condition Significant interstitial pneumonia or pulmonary fibrosis by CT scan or x-ray Suspected of infection with fever Symptomatic Varicella Requiring treatment of pleural or pericardial effusions Severe edema Severe peripheral neuropathy Requiring treatment with the steroid is a necessity beforehand Severe psychiatric disorders Inflammatory breast cancer

Related Information

• Primary Sponsor: Organization for Oncology and Translational Research (OOTR)
• Source(s) of Monetary Support: Organization for Oncology and Translational Research (OOTR)