UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010227 |
|---|---|
| Receipt number | R000011974 |
| Scientific Title | Multicenter phase II trial of neoadjuvant chemotherapy with trastuzumab, docetaxel, and carboplatin for HER2-positive operable breast cancer: KBOG-1204 trial |
| Date of disclosure of the study information | 2013/03/12 |
| Last modified on | 2018/08/03 11:07:16 |
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Basic information
Public title
Multicenter phase II trial of neoadjuvant chemotherapy with trastuzumab, docetaxel, and carboplatin for HER2-positive operable breast cancer: KBOG-1204 trial
Acronym
Neoadjuvant TCbH therapy for HER2-positive breast cancer: KBOG-1204 trial
Scientific Title
Multicenter phase II trial of neoadjuvant chemotherapy with trastuzumab, docetaxel, and carboplatin for HER2-positive operable breast cancer: KBOG-1204 trial
Scientific Title:Acronym
Neoadjuvant TCbH therapy for HER2-positive breast cancer: KBOG-1204 trial
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy (histopathological response)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological complete response rate
Key secondary outcomes
Cardiac adverse events, Breast-conserving rate, Clinical response rate, Relapse-free survival, Overall survival
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
Neoaduvant chemotherapy with Docetaxel+Carboplatin+Trastuzumab
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1) invasive breast cancer by needle biopsy
2) operable primary breast cancer
3) HER2 positive (IHC 3+ or FISH +)
4) ER, PgR known
5) P.S. = 0~1
6) measurable lesions
7) preserving the functions of bone marrow, heart, liver, and kidney
8) written informed consent
Key exclusion criteria
1) drug allergy
2) severe complications (malignant hypertension, congestive heart failure, coronary heart disease, myocardial infarction (onset within 6 months), arrhythmia (treated), infectious disease, bleeding tendency, etc)
3) feber, infection
4) peripheral neuropathy
5) pleural effusion, pericardial effusion
6) active double cancer
7) inflammatory breast cancer
8) bilateral breast cancer, male breast cancer
9) pregnancy
10) severe edema
11) interstitial pneumonia, fibrous lung disease
12) steroid-using patients
13) psychosomatic disease
14) unsuitable patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Tsugawa, M.D. |
Organization
St. Marianna University School of Medicine
Division name
Department of Surgery, Division of Breast and Endocrine Surgery
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL
044-977-8111
koitsuga@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kojima, M.D. |
Organization
St. Marianna University School of Medicine
Division name
Department of Surgery, Division of Breast and Endocrine Surgery
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
kojiyasu@marianna-u.ac.jp
Sponsor or person
Institute
Kanagawa Breast Oncology Group (KBOG)
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Breast Oncology Group (KBOG)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
東海大学付属病院、聖マリアンナ医科大学病院、聖マリアンナ医科大学附属ブレスト＆イメージングセンター、横浜市立大学附属市民総合医療センター、北里大学病院、神奈川県立がんセンター、大船中央病院、横浜労災病院、湘南記念病院、みなと赤十字病院、横浜旭中央総合病院、東海大学付属八王子病院、横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 12 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 12 | Day |
Last modified on
| 2018 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011974
