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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030215
Receipt No. 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

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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
Email 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
Email sakashi@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034515

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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