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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001582
Receipt No. R000001768
Scientific Title Feasibility study of TC(docetaxel+Cyclophosphamide)as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor(KBC-SG 0803)
Date of disclosure of the study information 2008/12/17
Last modified on 2010/08/04

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Basic information
Public title Feasibility study of TC(docetaxel+Cyclophosphamide)as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor(KBC-SG 0803)
Acronym Feasibility study of TC (docetaxel+cyclophosphamide) as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor (KBC-SG 0803)
Scientific Title Feasibility study of TC(docetaxel+Cyclophosphamide)as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor(KBC-SG 0803)
Scientific Title:Acronym Feasibility study of TC (docetaxel+cyclophosphamide) as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor (KBC-SG 0803)
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Medicine in general Hematology and clinical oncology Surgery in general
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the completion rate for 4 cycles of adjuvant chemothrapy as docetaxel plus cyclophosphamide (TC) regimen for patients who will have an intermediate risk primary breast cancer with HER2-negtive and ER-positive.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes completion rate
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 4 cycles of TC (Docetaxel 75 mg/m2 / Cyclophosphamide 600mg/m2), every 3 weeks
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
70 years-old >=
Gender Female
Key inclusion criteria 1.Primary breast cancer patients with negative HER2 excluded HER2 3+ by IHC3 or positive by FISH,and ER positive breast dancer.
Intermediate risk for recurrence according to the classification proposed by the 10th International Symposium on Primary Therapy of Breast Cancer (St.Gallen, 2007)
2.ECOG Performance status 0-1
3.Within 6 weeks after surgery
4.No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy for present primary breast cancer
5.Sufficient organ function (e.g. bone marrow, cardiac, liver and renal)
6.Written informed consent
Key exclusion criteria 1.History of bilateral breast cancer
2.History of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
3.Inflammatory breast cancer
4.Male
5.A history of hypersensitivity reaction to any drugs.
6.Uncontrolled medical conditions.
7.Suspected of infection with fever
8.Severe peripheral neuropathy (>grade 1)
9.Symptomatic varicella.
10.HBs antigen positive
11.Treatment required pleural or pericardial effusions
12.Severe peripheral edema (>grade 1)
13.Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray
14.Patients who are required concurrent treatment by corticosteroids except for premedication
15.Severe psychiatric disorders
16.Pregnant or lactation women, or women with suspected pregnancy
17.Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size 102

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Tamura
Organization Fukuoka University
Division name The Department of Medicine, Division of Medical Oncology,Infectious Disease, and Endocrinology School of Medicine
Zip code
Address 7-45-1 Nanakuma Jonan-ku Fukuoka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Tamura
Organization Kyushu Breast Cancer Study Group
Division name Executive office
Zip code
Address 7-45-1 Nanakuma Jonan-ku Fukuoka
TEL 092-801-2845
Homepage URL http://www.chotsg.com
Email

Sponsor
Institute Kyushu Breast Cancer Study Group
Institute
Department

Funding Source
Organization Non-profit Organization Clinical Henmatology/Oncology Study Group
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2008 Year 12 Month 17 Day

Related information
URL releasing protocol http://www.chotsg.com
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 Completed
Date of protocol fixation
2008 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2015 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 12 Month 17 Day
Last modified on
2010 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001768

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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