UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000263 |
|---|---|
| Receipt number | R000000331 |
| Scientific Title | First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study |
| Date of disclosure of the study information | 2005/10/15 |
| Last modified on | 2010/04/15 23:20:54 |
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Basic information
Public title
First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study
Acronym
First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study(Her-mono study)
Scientific Title
First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study
Scientific Title:Acronym
First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study(Her-mono study)
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and safety of first-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
Progression-free survival(PFS)
Overall survival(OS)
adverse event(AE)
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
chemotherapy(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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Histologically confirmed mastocarcinoma
No previous treatment except for endocrine therapy
HER2 status of primary or metastatic tumour was assessed positive
Measurable or evaluable lesion
ECOG performance status 0,1 or 2
Age: 20-75 years old
Ample organ function
Signed informed consent
Key exclusion criteria
Documented history of serious hypersensitivity reaction on the medical drugs
Severe complication
Fever, suspicious of infection
Severe pleural fluid and pericardial effusion
Symptomatic brain metastasis
Active double cancer
Interstitial pneumonia or pulmonary fibrosis
Neuropathy
Grade 2,3 or 4 edema
Pregnant or lactating women
Doctor' s decision for exclusion
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norikazu Masuda |
Organization
Osaka National Hospital
Division name
Department of Surgery(Breast Oncology)
Zip code
Address
1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL
06-6942-1331
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
H/D study group on Breast Cancer
Division name
Executive Office
Zip code
Address
1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL
06-6942-1331
Homepage URL
Sponsor or person
Institute
H/D study group on Breast Cancer
Institute
Department
Personal name
Funding Source
Organization
H/D study group on Breast Cancer
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
| 2005 | Year | 10 | Month | 15 | 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
| 2002 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 01 | 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
| 2005 | Year | 10 | Month | 15 | Day |
Last modified on
| 2010 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000331
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
