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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006673
Receipt No. R000007882
Scientific Title Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.
Date of disclosure of the study information 2011/11/07
Last modified on 2017/10/05

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Basic information
Public title Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.
Acronym Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.
Scientific Title Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hajime Abe
Organization Shiga University of Medical Science
Division name Division of Breast and General Surgery
Zip code
Address Seta-Tsukinowa, Otsu, Shiga, 520-2192 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shiga University of Medical Science
Division name Division of Breast and General Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2011 Year 04 Month 17 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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