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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020837
Receipt No. 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

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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
Email 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
Email info@setouchi-bp.com

Sponsor
Institute Setouchi Breast Project Comprehensive Support Organization
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024054

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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