UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of pertuzumab and trastuzumab in combination with S-1 for patients with HER2-positive metastatic breast cancer
Acronym	Phase II trial of pertuzumab and trastuzumab in combination with S-1 for patients with HER2-positive metastatic breast cancer
Scientific Title	Phase II trial of pertuzumab and trastuzumab in combination with S-1 for patients with HER2-positive metastatic breast cancer
Scientific Title:Acronym	Phase II trial of pertuzumab and trastuzumab in combination with S-1 for patients with HER2-positive metastatic breast cancer
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 pertuzumab and trastuzumab in combination with S-1 for patients with HER2-positive metastatic breast cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Progression-free survival Overall survival Safety

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	Pertuzumab:420mg/body intravenously administred on day 1 every 3 weeks (loading dose:840mg/body) Trastuzumab:6mg/kg intravenously administred on day 1 every 3 weeks (loading dose:8mg/kg) S-1:80 mg/m2/day orally in 2 divided doses for 2 weeks followed by 1week rest
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.Histopathologically proven diagnosis of breast cancer 2.Advanced or metastatic recurrent breast cancer 3.HER2-positive(3+ staining by IHC or HER2 gene amplification by FISH)metastatic breast cancer 4.The criteria for previous treatment as following: (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 5.No prior treatment by S-1 for present primary breast cancer 6.Patients with measurable lesion 7.Age at consent is >= 20 8.ECOG performance status 0 to 2 9.Expected survival longer than 3 months 10.Sufficient functions of important organs WBC>=3,000/mm3 <=12,000/mm3 Neurtophils>=1,500/mm3 Platelets>=100,000/mm3 Hemoglobin>=9.0g/dL Total bilirubin <= ULN AST(GOT)<= ULNx2.5(<= ULNx5.0 in case of liver metastasis) ALT(GPT)<= ULNx2.5(<= ULNx5.0 in case of liver metastasis) Serum Creatinine<=ULN Creatinine clearance >=50mL/minutes 11.Left ventricle ejection fraction 50 % or more by cardiac sonography or MUGA scan 12.All of HBs antigen, HBs antibody, HBc antibody and HCV antibody are negative 13.Written informed consent to participate
Key exclusion criteria	1.History of hypersensitivity reaction 2.Brain metastasis 3.Pleural effusion, ascites, and pericardial fluid requiring treatment 4.Active another cancer 5.Active infection 6.Other severe complications, such as heart failure, interstitial pneumonia and renal failure with clinically problem 7.Required treatment with steroid 8.Pregnant or possibility pregnancy or nursing women 9.Mental disorder which become problem on clinical practice 10.Physician judged improper to entry this trial
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Uhi Middle name Last name Toh
Organization	Kurume University School of Medicine
Division name	Department of Surgery
Zip code	8300011
Address	Dept. Surgery, Schl Of Medicine, Kurume University
TEL	0942317566
Email	utoh@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Toh Middle name Last name Uhi
Organization	Kurume University School
Division name	Department of Surgery
Zip code	8300011
Address	67 Asahi-machi,Kurume city,Fukuoka
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	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kurume University School Of Medicine
Address	Dept. Surgery, Schl Of Medicine, Kurume University
Tel	0942317566
Email	utoh@med.kurume-u.ac.jp

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	久留米大学病院

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 19 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	Suspended
Date of protocol fixation	2016 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 19 Day
Last follow-up date	2019 Year 09 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	2016 Year 10 Month 19 Day
Last modified on	2021 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028062