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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002310
Receipt No. R000002816
Scientific Title Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients without lymph node metastasis or with three and under lymph node metastasis.
Date of disclosure of the study information 2009/08/31
Last modified on 2014/03/27

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Basic information
Public title Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients without lymph node metastasis or with three and under lymph node metastasis.
Acronym Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients. (GBCRG-2surg-01)
Scientific Title Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients without lymph node metastasis or with three and under lymph node metastasis.
Scientific Title:Acronym Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients. (GBCRG-2surg-01)
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Endocrine surgery Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of adjuvant chemotherapy combined with docetaxel and cyclophosphamide for breast cancer patients without lymph node metastasis or with three and under lymph node metastasis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Safety
completion rate
Key secondary outcomes Disease free survival
Overall 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 four cycles of therapy, administered every 3 weeks.
Docetaxel (75 mg/m2) and Cyclophosphamide (600 mg/m2) are administered by intravenous infusion on day 1 in eacn cycle.
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) Histologically diagnosed breast cancer without lymph node metastasis or with three and under lymph node metastasis.
2)Age 20 to 70 years
3)ECOG PS 0 to 2
4)Previous endocrine therapy or chemotherapy for breast cancer.
5)Required baseline laboratory parameters
6)Without severe complications,ischemia attack, uncontrolled congestive heart failure
7)Written informed consent
Key exclusion criteria 1)Patients who received previous endocrine therapy or chemotherapy
2)Severe drug allergic history
3)Inflammatory breast cancer
4)Bilateral breast cancer in same time
5)Severe complications
6)Active double cancer
7)Inflammation with fever up
8)Neurological problem
9)Pleural effusion or pericardial effusion
10)Symptomatic brain metastasis
11)Pregnancy
12)Severe edema
13)Interstitial lung disease, pulmonary fibrosis
14)Psychiatric disease
15)Doctors decision for excluion
16)Low risk in St. Gallen Conferences 2007
17)16 weeks or more after operation
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nana Rokutanda
Organization Gunma University Graduate School of Medicine
Division name Thoracic Visceral Organ Surgery
Zip code
Address 3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan
TEL 027-220-8245
Email nana.rokutanda@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Nana Rokutanda
Organization Gunma Breast Cancer Research Group 2 surgery (GBCRG-2surg) 01
Division name Secretariat Division (Department of Thoracic Visceral Organ Surgery , Gunma University Graduate Scho
Zip code
Address 3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan
TEL 027-220-8245
Homepage URL
Email nana.rokutanda@gmail.com

Sponsor
Institute Gunma Breast Cancer Research Group 2 surgery
Institute
Department

Funding Source
Organization Department of Thoracic Visceral Organ Surgery ,
Gunma University Graduate Schol of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 08 Month 31 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 No longer recruiting
Date of protocol fixation
2009 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2016 Year 12 Month 01 Day
Date of closure to data entry
2016 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 09 Day
Last modified on
2014 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002816

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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