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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002651
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003228

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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