UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001582 |
|---|---|
| Receipt number | 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 15:19:45 |
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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
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
Sponsor or person
Institute
Kyushu Breast Cancer Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001768
