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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012256
Receipt No. R000014329
Scientific Title Pase II study of neoadjuvant chemotherapy with Docetaxel, Carboplatin, and Trastuzumab for operable Her2-positive breast cancer patients.
Date of disclosure of the study information 2013/11/09
Last modified on 2018/05/28

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Basic information
Public title Pase II study of neoadjuvant chemotherapy with Docetaxel, Carboplatin, and Trastuzumab for operable Her2-positive breast cancer patients.
Acronym KBC-SG 1201
Scientific Title Pase II study of neoadjuvant chemotherapy with Docetaxel, Carboplatin, and Trastuzumab for operable Her2-positive breast cancer patients.
Scientific Title:Acronym KBC-SG 1201
Region
Japan

Condition
Condition Her2-positive breast cancer
Classification by specialty
Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the anti-tumor effect of combination chemotherapy with Docetaxel, Carboplaitn, Trastuzumab in Her2-positive breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Pathological complete response rate.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Female
Key inclusion criteria 1. Women with histological confirmed invasive breast cancer at diagnosis.
2. Operable breast cancer. TMN:T1b-T3, N0-N2, M0
3. Her2(3+) by core needle biopsy before treatment and/or FISH(+)before registration.
4. At least one measurable region (RECIST version1.1).
5. No prior treatment for breast cancer.
6. PS:0-1
7. Adequate main organ function.
4000/mm3<=WBC <12000
and/or 2000/mm3<=neutorophil
PLT>=100000/mm3
AST, ALT<=ULN*2.5
T.Bil<=1.5mg/dl
Cr<=1.5mg/dl
Normal electrocardiogram.
LVEF: 55%<=
8. Written informed consent.
Key exclusion criteria 1.Clinically inadequate heart function at the registration and/or with past history.
2.Severe uncontrolled complications (Uncontrolled DM, HT, liver dysfunction, renal dysfunction, infection mental manifestation).
3.Women during pregnancy or shortly after childbirth.
4.Double active cancer (in less than 5 years after the last treatment).
5.Women with bilateral breast cancer (synchronous or heterochronous).
6.Women with pulmonary fibrosis and/or interstitial pneumonia.
7.Patients with allergy to the medicines in this protocol treatment.
8.Patients judged inappropriate for this study by the physicians.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohjiro Mashino
Organization Oita Prefectural Hospital
Division name Department of breast surgery
Zip code
Address Bunyo 476, Oita city, Oita
TEL 097-546-7111
Email mashino@oitakenbyo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Tamura
Organization Kyushu Breast Cancer Study Group
Division name Organizer
Zip code
Address 7-45-1, Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-2845
Homepage URL http://www.chotsg.com/kbc-sg/
Email kbc@chotsg.com

Sponsor
Institute Kyushu Breast Cancer Study Group
Institute
Department

Funding Source
Organization Non-profit organization, Clinical Hematology Oncology Treatment Study Group
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
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 大分県立病院(大分県)、福岡大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 09 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
2013 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study prospectively evaluate the anti-tumor effect , adverse event and tolerability of TCbH therapy in Japanese women.

Management information
Registered date
2013 Year 11 Month 09 Day
Last modified on
2018 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014329

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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