UMIN ID: UMIN000002310
Registered date:31/08/2009
Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients without lymph node metastasis or with three and under lymph node metastasis.
Basic Information
Recruitment status | Complete: follow-up continuing |
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Health condition(s) or Problem(s) studied | Breast cancer |
Date of first enrollment | 2009/07/01 |
Target sample size | 90 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | four cycles of therapy, administered every 3 weeks. Docetaxel (75 mg/m2) and Cyclophosphamide (600 mg/m2) are administered by intravenous infusion on day 1 in eacn cycle. |
Outcome(s)
Primary Outcome | Safety completion rate |
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Secondary Outcome | Disease free survival Overall survival |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 70years-old |
Gender | Female |
Include criteria | |
Exclude criteria | 1)Patients who received previous endocrine therapy or chemotherapy 2)Severe drug allergic history 3)Inflammatory breast cancer 4)Bilateral breast cancer in same time 5)Severe complications 6)Active double cancer 7)Inflammation with fever up 8)Neurological problem 9)Pleural effusion or pericardial effusion 10)Symptomatic brain metastasis 11)Pregnancy 12)Severe edema 13)Interstitial lung disease, pulmonary fibrosis 14)Psychiatric disease 15)Doctors decision for excluion 16)Low risk in St. Gallen Conferences 2007 17)16 weeks or more after operation |
Related Information
Primary Sponsor | Gunma Breast Cancer Research Group 2 surgery |
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Secondary Sponsor | |
Source(s) of Monetary Support | Department of Thoracic Visceral Organ Surgery , Gunma University Graduate Schol of Medicine |
Secondary ID(s) |
Contact
public contact | |
Name | Nana Rokutanda |
Address | 3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan Japan |
Telephone | 027-220-8245 |
nana.rokutanda@gmail.com | |
Affiliation | Gunma Breast Cancer Research Group 2 surgery (GBCRG-2surg) 01 Secretariat Division (Department of Thoracic Visceral Organ Surgery , Gunma University Graduate Scho |
scientific contact | |
Name | Nana Rokutanda |
Address | 3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan Japan |
Telephone | 027-220-8245 |
nana.rokutanda@gmail.com | |
Affiliation | Gunma University Graduate School of Medicine Thoracic Visceral Organ Surgery |