UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.
Title of the study (Brief title)	Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility of Docetaxel and Daily Oral Cyclophosphamide as adjuvant chemotherapy in patients with completely resected breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Feasibility
Key secondary outcomes	Safety, Disease-free survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Docetaxel 75mg/m2 day1, Cyclophosphamide 100mg/m2 day1-14 every 3 weeks, 4 cycles
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Female
Key inclusion criteria	1. Histologically deterimined breast cancer 2. Age 20 to 65 years 3. ECOG performance status 0 or 1 4. The patient of possible beginning of the treatment within four weeks after it operates 5. Previous endocrine therapy or chemotherapy for breast cancer 6. Required baseline laboratory parameters WBC >= 3,500/mm3 Neu >= 1,500/mm3 Hb >= 10.0g/dL Plt >= 100,000/mm3 T-Bil <= 1.5mg/dL AST <= 60 IU/L ALT <= 60 IU/L Cre <= 1.5mg/dL normal ECG 7. Written informed consent
Key exclusion criteria	1. Bilateral breast cancer in same time 2. Active double cancer 3. Inflammatory breast cancer 4. Male breast cancer 5. Severe drug allergic history 6. Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infartion within 6 months, liver cirrhosis, uncontrolled diabetes, hemorrhagic tendency) 7. Active infections 8. Peripheral nerve disorders 9. Massive pleural or pericardial effusion 10. Severe edema 11. Interstitial lung disease, pulmonary fibrosis 12. The case which has an underlying disease which needs combined use with steroid 13. Psychiatric disease 14. Pregnant or lactating women 15. Other conditions not suitable for this study 16. Allergy against polysorbert 80
Target sample size	20

Research contact person
Name of lead principal investigator	Hajime Abe
Organization	Shiga University of Medical Science
Division name	Division of Breast and General Surgery
Address	Seta-Tsukinowa, Otsu, Shiga, 520-2192 Japan
TEL
Email

Public contact
Name of contact person
Organization	Shiga University of Medical Science
Division name	Division of Breast and General Surgery
Address	Seta-Tsukinowa, Otsu, Shiga, 520-2192 Japan
TEL
Homepage URL
Email

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 04 Month 17 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 11 Month 04 Day
Last modified on	2017 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007882