UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030780 |
|---|---|
| Receipt number | R000034530 |
| Scientific Title | Phase 3 Trial of Carboplatin in Triple Negative Breast Cancer Patient with Residual Invasive Carcinoma After Neoadjuvant Chemotherapy(Transitioned to jRCT) |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2023/07/24 16:11:38 |
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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(Transitioned to jRCT)
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(Transitioned to jRCT)
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
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
htanino@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 08 | Day |
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
Transitioned to jRCT,jRCTs051180210
Management information
Registered date
| 2018 | Year | 01 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034530
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| Registered date | File name |
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| Registered date | File name |
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| Registered date | File name |
