UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pase II study of neoadjuvant chemotherapy with Docetaxel, Carboplatin, and Trastuzumab for operable Her2-positive breast cancer patients.
Title of the study (Brief title)	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	Kohjiro Mashino
Organization	Oita Prefectural Hospital
Division name	Department of breast surgery
Address	Bunyo 476, Oita city, Oita
TEL	097-546-7111
Email	mashino@oitakenbyo.jp

Public contact
Name of contact person	Kazuo Tamura
Organization	Kyushu Breast Cancer Study Group
Division name	Organizer
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014329