UMIN ID: UMIN000001077
Registered date:13/03/2008
Fluorouracil / Epirubicin / Cyclophosphamide (FEC) followed by Docetaxel plus Cyclophosphamide (TC) as adjuvant chemotherapy for node positive breast cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | BreastCancer |
| Date of first enrollment | 2006/07/01 |
| Target sample size | 35 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | FEC followed by Docetaxel 75 mg/m2, IV, Day 1 Cyclophosphamide 600mg/m2, IV, Day 1 Every 21 days for 4 cycles |
Outcome(s)
| Primary Outcome | Completion rate of planned treatment cycles |
|---|---|
| Secondary Outcome | toxicity Mean delivered treatment course Relative dose-intensity |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 70years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | Patients who have received any prior therapy (hormonal therapy, chemotherapy, etc.) Pregnant or lactation women History of hypersensitivity reaction to drugs formulated with polysorbate Distant metastasis Patients judged by the investigator to be unfit to be enrolled into the study |
Related Information
| Primary Sponsor | Kinki Multidisciplinary Breast Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Sakai Clinical Research Supporting Center(SCRSC) |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Norikazu Masuda |
| Address | Osaka National Hospital, Department of Surgery Japan |
| Telephone | 06-6942-1331 |
| Affiliation | Kinki Multidisciplinary Breast Oncology Group Secretariat office |
| scientific contact | |
| Name | Norikazu Masuda |
| Address | 2-1-14 Hoenzaka, Chuo-ku, Osaka, JAPAN 540-0006 Japan |
| Telephone | 06-6942-1331 |
| Affiliation | Osaka Medical Center Surgery |