UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013274 |
|---|---|
| Receipt number | 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 16:00:06 |
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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
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
tsitomu-@rd5.so-net.ne.jp
Sponsor or person
Institute
Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014186
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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