UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002651 |
|---|---|
| Receipt number | R000003228 |
| Scientific Title | A Phase II Trial of Lapatinib and Trastuzumab in Patients with Heavily Pretreated Metastatic Breast Cancer |
| Date of disclosure of the study information | 2009/11/10 |
| Last modified on | 2010/07/20 21:58:52 |
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Basic information
Public title
A Phase II Trial of Lapatinib and Trastuzumab in Patients with Heavily Pretreated Metastatic Breast Cancer
Acronym
A Phase II Trial of Lapatinib and Trastuzumab in Patients with Heavily Pretreated Metastatic Breast Cancer
Scientific Title
A Phase II Trial of Lapatinib and Trastuzumab in Patients with Heavily Pretreated Metastatic Breast Cancer
Scientific Title:Acronym
A Phase II Trial of Lapatinib and Trastuzumab in Patients with Heavily Pretreated Metastatic Breast Cancer
Region
| Japan |
Condition
Condition
HER2 positive breast cancer patients treted with multiple cytotoxic agent including trastuzumab
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine safety and efficacy of lapatinib and trastuzumab combination therapy in patients with heavily pretreated HER2 positive breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
overall survival, progression free survival, adverse event
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
Lapatinib
Trastuzumab
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a) HER2 positive advanced breast cancer
b) Anthracycline, taxanes, fluorouracil, vincaalkanoid, and trastzumab pretreated
c) PS 0-2
d) New York Heart Association classification<II
e) Target lesion required by RECIST
Key exclusion criteria
a) Lapatinib pretreated
b) Ejectoon fraction <50%
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikako Shimizu |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology Division
Zip code
Address
5-1-1, Tsukiji, Chuuou-ku, Tokyo, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Hashimoto |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology Division
Zip code
Address
5-1-1, Tsukiji, Chuuou-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
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
国立がんセンター中央病院 (東京都)
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 21 | Day |
Last modified on
| 2010 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003228
