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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000024477
Receipt No. R000028062
Scientific Title Phase II trial of pertuzumab and trastuzumab in combination with S-1 for patients with HER2-positive metastatic breast cancer
Date of disclosure of the study information 2016/10/19
Last modified on 2019/01/08

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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
Middle name
Last name Toh Uhi
Organization Kurume University School
of Medicine
Division name Department of Surgery
Zip code
Address 67 Asahi-machi,Kurume city,Fukuoka
TEL 0942-31-7566
Email utoh@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toh Uhi
Organization Kurume University School
Division name Department of Surgery
Zip code
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
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

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
2019 Year 01 Month 08 Day


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

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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