UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024477 |
|---|---|
| Receipt number | 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 | 2021/04/23 21:54:51 |
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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 | 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
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
utoh@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School
of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028062
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| Registered date | File name |
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