UMIN-CTR Clinical Trial

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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