UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020837 |
|---|---|
| Receipt number | R000024054 |
| Scientific Title | Effect of Additional pertuzumab for the post treatment in Patients with HER2 positive locally advanced/ metastatic Breast Cancer Who Were Previously Treated with pertuzumab - Phase II study - |
| Date of disclosure of the study information | 2016/02/02 |
| Last modified on | 2019/01/22 19:07:38 |
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Basic information
Public title
Effect of Additional pertuzumab for the post treatment in Patients with HER2 positive locally advanced/ metastatic Breast Cancer Who Were Previously Treated with pertuzumab - Phase II study -
Acronym
Clinical evaluation of re-administratoin of additional pertuzumab (SBP-08: Beyond pertuzumab study)
Scientific Title
Effect of Additional pertuzumab for the post treatment in Patients with HER2 positive locally advanced/ metastatic Breast Cancer Who Were Previously Treated with pertuzumab - Phase II study -
Scientific Title:Acronym
Clinical evaluation of re-administratoin of additional pertuzumab (SBP-08: Beyond pertuzumab study)
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of additional pertuzumab for the HER2 MBC previously treated with pertuzumab with or without TDM-1 after the progression of the initial HER2 targeting therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical benefit rate
Key secondary outcomes
PFS, OS, response rate, response rate of the initial therapy, 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
Add pertuzumab after the progression of the initial HER2 targeting therapy ( trastuzumab with either 1: vinorelbine, 2: paclitaxel or 3: eribulin) .
Initial HER2 targeting therapy as;
1 vinorelbine 25 mg/ m2 day 1, 8 (q21)
trastuzumab 6 mg/ kg day 1 ( induction dose: 8mg/ kg) (q21).
2 paclitaxel 80mg/m2 day 1, 8, 15 (q21)
trastuzumab 6 mg/ kg day 1 ( induction dose: 8mg/ kg) ( q21).
3 eribulin 1.4mg/m2 day 1, 8 (q21)
trastuzumab 6 mg/ kg day 1 ( induction dose : 8mg/ kg ) (q21).
After the progression of the initial HER2 targeting therapy ( either 1, 2 or 3), add pertuzumab, initially 840mg day 1, then 420mg day 1 (q21), until further progression or meeting the criterion of discontinuation.
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1 informed consent
2 age >=20
3 locally advanced/ metastatic breast cancer histologically confirmed
4 HER2 breast cancer( FISH positive or IHC 3+)
5 MBC pretreated with pertuzumab containing regimens
6 ECOG PS: 0-2
7 non-hematological AE( CTCAE v4.0-JCOG) <= grade 2
8 survival expectancy >= 3 months
9 with or without evaluable lesions
10 EF>=50
11 untreated with either vinorelbine, paclitaxel or eribulin
12 non major organ dysfunction within the criteria below;
for the VNR regimens:
1 neutrophil >=1000/mm3
2 PLT >=75000/mm3
3 Hb >=8.0 g/dL
4 T.Bil <=2 X ULN
5 AST, ALT <=3 X ULN (5 X ULN in the cases of liver
metastasis)
6 Cr <= 1.5 mg/dL
for the PTX regimens:
1 neutrophil >=1500/mm3
2 PLT >=100000/mm3
3 Hb >=8.0 g/dL
4 T.Bil <=2 X ULN
5 AST, ALT <=3 X ULN (5 X ULN in the cases of liver
metastasis)
6 Cr <= 1.5 mg/dL
for the ERI regimens:
1 neutrophil >=1500/mm3
2 PLT >=75000/mm3
3 Hb >=8.0 g/dL
4 T.Bil <=2 X ULN
5 AST, ALT <=3 X ULN (5 X ULN in the cases of liver
metastasis)
6 Cr <= 1.5 mg/dL
Key exclusion criteria
1 pretreated with all of VNR, PTX and ERI
2 allergic for VNR, PTX, ERI, polyoxyethylene castor oil, CHO or recombinant humanized monoclonal antibody
3 symptomatic brain metastasis
4 pregnancy or breast feeding or unwilling to contraception
5 uncontrolled hypertension, symptomatic heart failure, unstable angina, severe arrhythmia or acute myocardial infarction within 12 months
6 obvious pulmonary fibrosis or interstitial pneumonia
7 EF <50%
8 active infection
9 no other severe comorbidity
10 no another active cancer
11 other inappropriate patients
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Kubo |
Organization
Fukuyama city hospital
Division name
Department of Breast and thyroid surgery
Zip code
Address
5-23-1 Zao-cho, Fukuyama city , Hiroshisma
TEL
084-941-5151
shikubo@city.fukuyama.hiroshima.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taira Naruto |
Organization
Setouchi Breast Project Comprehensive Support Organization
Division name
Clinical trial committee
Zip code
Address
2-5-1, Shikata, Kita-ku, Okayama
TEL
086-235-7265
Homepage URL
info@setouchi-bp.com
Sponsor or person
Institute
Setouchi Breast Project Comprehensive Support Organization
Institute
Department
Personal name
Funding Source
Organization
Setouchi Breast Project Comprehensive Support Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 02 | Month | 02 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024054
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