UMIN ID: UMIN000001076
Registered date:13/03/2008
Docetaxel plus cyclophophamide as adjuvant chemotherapy for negative axillary lymph node breast cancer
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Breast Cancer |
Date of first enrollment | 2006/07/01 |
Target sample size | 35 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Docetaxel 75 mg/m2, IV, Day 1 Cyclophosphamide 600mg/m2, IV, Day 1 Every 21 days for 6 cycles |
Outcome(s)
Primary Outcome | Planned treatment completion rate |
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Secondary Outcome | Toxicity, Mean delivered treatment course, Relative dose-intensity |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | 70years-old |
Gender | Female |
Include criteria | |
Exclude criteria | Histologically proven female breast cancer who underwent complete surgical excision No incidence of axillary metastasis by lymph node dissection or sentinel node biopsy Age >= 20 to =<34 or >=35 to =<70 who fills one of the followings (St.Gallen category of node-negative with intermediate risk) Tumor size >2cm Histologic and / or nuclear grade2-3 Presence of peritumoral vascular invasion HER2 IHC (3+) or FISH (+) ER (-) ECOG PS 0-1 No more than 2 weeks from the lastsurgery Patients were required to have leukocyte >= 4000/mm3 or neutrophil >= 2000/mm3 hemoglobin >= 10 g/dL platelet count >= 100,000/ mm3 total bilirubin =< 1.5 mg/dL AST =< 2.5x the upper limit of normal serum creatinine less than 1.5 mg/dL Sufficient organ function Written informed consent |
Related Information
Primary Sponsor | Kinki Multidisciplinary Breast Oncology Group |
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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 |