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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030780
Receipt No. R000034530
Scientific Title Phase 3 Trial of Carboplatin in Triple Negative Breast Cancer Patient with Residual Invasive Carcinoma After Neoadjuvant Chemotherapy
Date of disclosure of the study information 2018/03/01
Last modified on 2018/01/12

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Basic information
Public title Phase 3 Trial of Carboplatin in Triple Negative Breast Cancer Patient with Residual Invasive Carcinoma After Neoadjuvant Chemotherapy
Acronym P3 Trial of Cb on non pCR TNBC
Scientific Title Phase 3 Trial of Carboplatin in Triple Negative Breast Cancer Patient with Residual Invasive Carcinoma After Neoadjuvant Chemotherapy
Scientific Title:Acronym P3 Trial of Cb on non pCR TNBC
Region
Japan

Condition
Condition Triple Negative Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We planned to observe the efficacy of Caboplatin to reduce the recurrence rate on the triple negative breast cancer patients with residual invasive cancer on the surgical specimens after preoperative Anthracycrine and Taxan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes 3 years of disease free survival
Key secondary outcomes Safety, 5 years of over all survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Observation
Interventions/Control_2 Carboplatin AUC6 q3wks x4
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
80 years-old >
Gender Female
Key inclusion criteria (1) Triple negative breast cancer patients
i) ER and PgR negative (IHC<10 %)
ii) HER2 negative (IHC 1+/0 or IHC 2+/FISH-)
(2) Patients who received Anthracycrine and Taxan treatment preoperatively.
(3) Patients with residual invasive cancer or lymph node metastasis on surgical specimens
(4) Within 3 months after surgery
(5) Written consent
Key exclusion criteria (1) previously treated with Carboplatin
(2) other cancer
(3) bilateral breast cancer
(4) during pregnancy or breast feeding
(5) attended clinical trial within 6 month
(6) metastatic breast cancer
(7) heavy disorder of heat, kidney or liver
(8) doctor's dicision of inadequacy
Target sample size 270

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu Tanino MD, PhD
Organization Kobe University Hospital
Division name Department of Breast Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017 Japan
TEL 078-382-5111
Email htanino@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Tanino MD, PhD
Organization Kobe University Hospital
Division name Department of Breast Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017 Japan
TEL 078-382-5111
Homepage URL
Email htanino@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
Organization
Division
Category of Funding Organization Other
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 弘前市立病院(青森)、弘前大学(青森)、千葉医療センター(千葉)、千葉がんセンター(千葉)、千葉大学(千葉)、東京医科大学(東京)、虎の門病院(東京)、聖マリアンナ医科大学(神奈川)、横浜労災病院(神奈川)、横浜市立大学附属市民総合医療センター(神奈川)、北里大学(神奈川)、新潟大学(新潟)、愛知医科大学(愛知)、岐阜大学(岐阜)、京都府立医科大学(京都)、淀川キリスト教病院(大阪)、関西労災病院(大阪)、兵庫医科大学(兵庫)、神鋼病院(兵庫)、神戸中央市民病院(兵庫)、神戸大学(兵庫)、海星病院(兵庫)、兵庫がんセンター(兵庫)、熊本大学(熊本)、相良病院(鹿児島)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2023 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 12 Day
Last modified on
2018 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034530

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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