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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001583
Receipt No. R000001771
Scientific Title Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer
Date of disclosure of the study information 2008/12/17
Last modified on 2018/05/14

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Basic information
Public title Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer
Acronym Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer
Scientific Title Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer
Scientific Title:Acronym Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer
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 Confirmation of the treatment feasibility with 5-fuluorouracil/epirubicin/cyclophosphamide (FEC) followed by docetaxel/trastuzumab (DH) as adjuvant therapy for early breast cancer with positive HER2 protain or over-expression of HER2 gene (KBC-SG 0802).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Completion rate of the treatment according with the protocol
Key secondary outcomes Safety
Postponement rate as compared to planned treatment schedule
Dose reduction rate as compared to planned doses of chemotherapeutic agents

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 As FEC regimen, 5-fluorouracil 500 mg/m2 iv, epirubicine 100 mg/m2 iv and cyclophophamide 500 mg/m2 iv every 3 weeks, repeated 4 cycles

Docetaxel 75 mg/m2 iv every 3 weeks, repeated 4 cycles following FEC.
Trastuzumab beginning with a loading dose of 8 mg/kg of body weight, iv given with the first dose of Docetaxel and followed by does of 6 mg/kg iv every 3 weeks, repeated 4 cycles.

Total duration of trastuzumab will be 1 year.

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. ECOG Performance status 0-1
2. positive HER2 protain (IHC) or over-expression of HER2 gene (FISH)
3. Sufficient organ function (e.g. bone marrow, cardiac, liver and renal)
4. Primary breast cancer patients pN0-3 who underwent curative mastectomy and lymph-node dissection including negative sentinel lymph nodes
5.Within 6 weeks after surgery
6. No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy for present primary breast cancer
7. Written informed consent

Key exclusion criteria 1. Clinical or radiological evidence of metastatic breast cancer
2. complication of the active other malignancies
3. Serious cardiac disfunction
4. Uncontrolled medical conditions
5. Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray
6. Patients who are required concurrent treatment by corticosteroids except for premedication
7 .Severe psychiatric disorders
8. Pregnant or lactation women, or women with suspected pregnancy
9. History of hypersensitivity reaction to drug formulated with Polysorbate 80
10. Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size 45

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 092-801-1011
Email ktamura@fukuoka-u.ac.jp

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 1-8-17-204, Watanabe-dori, chuo-ku, Fukuoka
TEL 092-406-4166
Homepage URL http://www.chotsg.com
Email npo@chotsg.com

Sponsor
Institute Kyushu Breast Cancer Study Group
Institute
Department

Funding Source
Organization Non-profit Organization Clinical Hematology/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
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 01 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2011 Year 12 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
2018 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001771

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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