UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of TS-1 / CPT-11 plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC02)
Title of the study (Brief title)	Prospective study of TS-1 / CPT-11 plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC02)
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of TS-1 / CPT-11 plus Trastuzumab in patients with HER-2 positive metastatic breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival(PFS)
Key secondary outcomes

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	TS-1 (80 mg/m2/day) is administered orally on days 3-7, 10-15 and 17-21. CPT-11 (60mg/m2) is injected by vein on day1, 8 and 15. Trastuzumab (4 mg/kg for the initial dosing and 2 mg/kg for subsequent administration, day1, 8, 15, 22 Cycles are repeated every 4 weeks.
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.Histological and/or cytological confirmed breast cancer 2.Metastatic breast cancer 3.HER2 positive (3+ staining by IHC or HER2 gene amplification by FISH) confirmed in the invasive component of the primary or metastatic lesion 4.age: >=20 and <80 5.Performance Status: 0-2 (ECOG) 6.The below criteria are met about prior therapy (1)chemotherapy: more than 7 days passed after chemotherapy (2)hormonal therapy: more than 7 days passed after hormonal therapy (3)radiation: more than 14 days passed after radiation. 7.expected survival longer than 3 months 8.With ability of oral intake 9.Sufficient function of important organs within 7 days prior to entry (1)WBC between 3,000/mm3 and 12,000/mm3 (2)Granulocyte count 1,500/mm3 or over (3)Platelet count 100,000/mm3 or over (4)Hb 9.0 g/dL or over (5)Total bilirubin <= the upper limit of normal range in each institute (6)AST(GOT) <=2.5 times of the upper limit of normal range in each institute (7)ALT(GPT) <=2.5 times of the upper limit of normal range in each institute (8)Serum creatinine <= the upper limit of normal range in each institute (9)Left ventricle ejection fraction 50 % or over by cardiac sonography or MUGA scan (10)Ccr: >=50 ml/min 10.Written informed consent to participate
Key exclusion criteria	1.With contraindicate TS-1, CPT-11 and Trastuzumab 2.With active double cancer 3.With uncontrolled diabetes 4.Heart failure with clinically problem 5.Symptomatic brain metastasis 6.With mental disorder which become problem on clinical practice 7.With uncontrolled hypertension 8.Physician judged improper to entry this trial
Target sample size	30

Research contact person
Name of lead principal investigator	Toh Uhi
Organization	Kurume University School of Medicine
Division name	Department of Surgery
Address	67 Asahi-machi,Kurume city,Fukuoka
TEL	0942-35-3311
Email	utoh@med.kurume-u.ac.jp

Public contact
Name of contact person	Toh Uhi
Organization	Kurume University School of Medicine
Division name	Department of Surgery
Address	67 Asahi-machi
TEL	0942-31-7566
Homepage URL
Email	utoh@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University School of Medicine
Institute
Department

Funding Source
Organization	Kurume University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 08 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 08 Month 25 Day
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2014 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 08 Day
Last modified on	2019 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010159