NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment2009/07/01
Target sample size90
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeSafety completion rate
Secondary OutcomeDisease free survival Overall survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderFemale
Include criteria
Exclude criteria1)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

Contact

public contact
Name Nana Rokutanda
Address 3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan Japan
Telephone 027-220-8245
E-mail 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
E-mail nana.rokutanda@gmail.com
Affiliation Gunma University Graduate School of Medicine Thoracic Visceral Organ Surgery