NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000429

Registered date:14/06/2006

oral CEF(Cyclophosphamide, Epirubicin, UFT) adjuvant chemotherapy for breast cancer with intra-patient dose escalation

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment2006/07/01
Target sample size26
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Adjuvant chemotherapy with oral cyclophosphamide and UFT with intra-patient dose escalation (Epirubicin)

Outcome(s)

Primary OutcomeMaximum tolerated dose (MTD) in oral CEF chemotherapy with intra-patient dose escalation
Secondary OutcomeDisease free survival time Adverse events graded by CTC

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum69years-old
GenderFemale
Include criteria
Exclude criteriaInfection, Fever = or > 38C Serious comorbidity Interstitial pneumonitis/fibrosis Peripheral neuropathy/edema Positive HBsAg Prior use of Anthracycline Decision by primary physician

Related Information

Contact

public contact
Name Hiroshi Ishiguro, MD, PhD
Address 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan 606-8507 Japan
Telephone 075-751-4770
E-mail hkkishi@kuhp.kyoto-u.ac.jp
Affiliation Kyoto University Hospital Outpatient Oncology Unit
scientific contact
Name Hiroshi Ishiguro, MD, PhD
Address 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan 606-8507 Japan
Telephone 075-751-4770
E-mail hkkishi@kuhp.kyoto-u.ac.jp
Affiliation Kyoto University Hospital Outpatient Oncology Unit