UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012256
Receipt number 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 17:25:48

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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 or person

Institute

Kyushu Breast Cancer Study Group

Institute

Department

Personal name



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

Value
https://center6.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