UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030215 |
|---|---|
| Receipt number | R000034515 |
| Scientific Title | neoadjuvant chemotherapy with gemcitabin plus carboplatin for triple negative breast cancer |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2019/06/04 16:23:33 |
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Basic information
Public title
neoadjuvant chemotherapy with gemcitabin plus carboplatin for triple negative breast cancer
Acronym
NAC with Gem/Carbo for TNBC
Scientific Title
neoadjuvant chemotherapy with gemcitabin plus carboplatin for triple negative breast cancer
Scientific Title:Acronym
NAC with Gem/Carbo for TNBC
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of neoadjuvant chemotherapy with platinum salts for triple negative breast cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
clinical response
Key secondary outcomes
pathological response
breast conserving rate
adverse effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
gemcitabin+carboplatin 4cycles followed by FEC 4 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) histological proven invasive breast cancer
2) ER- PgR- Her2-
3) StageII - IIIB
4) surgery is planned after chemotherapy
5) measurable tumor
Key exclusion criteria
1) severe drug hypersensitivity
2) previous malignancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Nakamura |
Organization
Showa University
Division name
Breast Surgery
Zip code
Address
Hatanodai 1-5-8, Shinagawa-ku, Tokyo
TEL
81-3-3784-8000
seigonak@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sadako Akashi-Tanaka |
Organization
Showa University
Division name
Breast Surgery
Zip code
Address
Hatanodai 1-5-8, Shinagawa-ku, Tokyo
TEL
81-3-3784-8000
Homepage URL
sakashi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 01 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034515
