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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013274
Receipt No. R000014186
Scientific Title Efficacy and feasibility study of docetaxel + capecitabine followed by FEC neoadjuvant therapy for hormone receptor positive and HER2 negative breast cancer
Date of disclosure of the study information 2014/02/25
Last modified on 2017/11/10

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Basic information
Public title Efficacy and feasibility study of docetaxel + capecitabine followed by FEC neoadjuvant therapy for hormone receptor positive and HER2 negative breast cancer
Acronym docetaxel + capecitabine followed by FEC neoadjuvant therapy for triple negative breast cancer
Scientific Title Efficacy and feasibility study of docetaxel + capecitabine followed by FEC neoadjuvant therapy for hormone receptor positive and HER2 negative breast cancer
Scientific Title:Acronym docetaxel + capecitabine followed by FEC neoadjuvant therapy for triple negative breast cancer
Region
Japan

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

Objectives
Narrative objectives1 To examine efficacy and feasibility of Docetaxel + Capecitabine followed by FEC100 neoadjuvant chemotherapy for triple negative breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes pathological CR rate, Feasibility, Overal response rate
Key secondary outcomes Adverse effects

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 Neoadjuvant Chemotherapy
Docetaxel + Capecitabine q 3wks x 3 cycles
follwed by
FEC q 3wks x 3 cycles
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
75 years-old >=
Gender Female
Key inclusion criteria 1 Histologically confirmed ER and PgR negative, HER2 negative invasive breast cancer.
2 ECOG PS 0-1
3 Tumor size >=1cm,N0-2, M0
4 Adequate visceral function
1) WBC >=3000/mm3
2) Hb >=8.0g/dL
3) Platelet >=100000/mm3
4) Total bilirubin <=1.5mg/dL
5) AST/ALT <= x 2.5 upper normal limits
6) serum Cr <=1.5mg/dL
5 Written informed consent
Key exclusion criteria 1 HER2 positive
2 Pregnant or breast feeding
3 Severe infectious disease
4 Active another cancer
5 Hypersensitivity for 5FU, docetaxel or polysolvate
6 Investigator's judgement of inappropriateness for perticipation
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Takashima
Organization Osaka City University Graduate School of Medicine
Division name Surgical Oncology
Zip code
Address 1-4-3 Asahimachi Abeno-Ku Osaka Japan
TEL 06-6645-3838
Email tsitomu-@rd5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Takashima
Organization Osaka City University Graduate School of Medicine
Division name Surgical Oncology
Zip code
Address 1-4-3 Asahimachi Abeno-Ku Osaka Japan
TEL 06-6645-3838
Homepage URL
Email tsitomu-@rd5.so-net.ne.jp

Sponsor
Institute Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Surgical Oncology, Osaka City University Graduate School 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 大阪市立大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 25 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
2012 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 25 Day
Last modified on
2017 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014186

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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