UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012375 |
|---|---|
| Receipt number | R000014468 |
| Scientific Title | A Pharmacokinetic and Phase II Study of Pertuzumab in Combination With Trastuzumab And Eribulin (Halaven) in Patients With Advanced HER2-Positive Breast Cancer |
| Date of disclosure of the study information | 2013/11/21 |
| Last modified on | 2016/06/14 10:32:51 |
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Basic information
Public title
A Pharmacokinetic and Phase II Study of Pertuzumab in Combination With Trastuzumab And Eribulin (Halaven) in Patients With Advanced HER2-Positive Breast Cancer
Acronym
HHP study
Scientific Title
A Pharmacokinetic and Phase II Study of Pertuzumab in Combination With Trastuzumab And Eribulin (Halaven) in Patients With Advanced HER2-Positive Breast Cancer
Scientific Title:Acronym
HHP study
Region
| Japan |
Condition
Condition
Advanced or recurrent human growth factor receptor 2 (HER2) -positive breast cancer patients
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate overall response rate, safety, duration of response, progression-free survival, clinical benefit rate and PK for the advanced or recurrent human growth factor receptor 2 (HER2) -positive breast cancer patients who are treated with eribulin and trastuzumub, pertuzumab which are monoclonal antibody drugs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective Response Rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) patients with history of prior treatment with anthracycline and taxane as pre/post-operative treatment or treatment to prevent recurrence.
(2) HER2-positive metastatic breast cancer
(3) ECOG perfomance status 0-1.
(4)patients with evaluable lesion by RECIST criteria.
(5)written informed consent was obtained
Key exclusion criteria
(1) Physician judged improper to entry this trial
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Araki |
Organization
The Cancer Institute Hospital of JFCR
Division name
Breast Oncology Center
Zip code
Address
3-8-31 Ariake Koutou-ku Tokyo,Japan
TEL
03-3520-0111
kazuhiro.araki@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satomi Ono |
Organization
Halaven study group
Division name
Research promotion group
Zip code
Address
Akasaka Intercity 11F, 1-11-44 Akasaka, Minato-ku, Tokyo,Japan
TEL
03-6229-8936
Homepage URL
halaven-study@mebix.co.jp
Sponsor or person
Institute
The Cancer Institute Hospital of JFCR
Institute
Department
Personal name
Funding Source
Organization
Eisai Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
公益財団法人がん研究会有明病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 21 | 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
| 2013 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To collect and evaluate real-life of patient with the advanced or recurrent HER2-positive breast cancer patients with pertuzumab and trastuzumab in combination with eribulin
Management information
Registered date
| 2013 | Year | 11 | Month | 21 | Day |
Last modified on
| 2016 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014468
