UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001408 |
|---|---|
| Receipt number | R000001640 |
| Scientific Title | A Phase II Study of Trastuzumab plus S-1 in Patients with Advanced or Recurrent HER2 positive Breast Cancer |
| Date of disclosure of the study information | 2008/10/01 |
| Last modified on | 2013/10/04 09:19:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Phase II Study of Trastuzumab plus S-1 in Patients with Advanced or Recurrent HER2 positive Breast Cancer
Acronym
A Phase II Study of Trastuzumab plus S-1 in Patients with Advanced or Recurrent HER2 positive Breast Cancer
Scientific Title
A Phase II Study of Trastuzumab plus S-1 in Patients with Advanced or Recurrent HER2 positive Breast Cancer
Scientific Title:Acronym
A Phase II Study of Trastuzumab plus S-1 in Patients with Advanced or Recurrent HER2 positive Breast Cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Endocrine surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of trastuzumab in combination with S-1 in patients with advanced/recurrent breast cancer with HER2 positive disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Safety
Overall survial
Progression free survival
Time to treatment failure
Biomarkers
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
S-1 80mg/m2 twice daily on days1-14 every 3 weeks.
Trastuzumab 6mg/kg (First time 8mg/kg) i.v., every 3 weeks
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Histologically diagnosed breast cancer
2) Advanced or recurrence breast cancer with measurable lesions
3) Diagnosed HER2 over expression (IHC score 3+ or FISH positive) in primary or metastatic site
4) 6 months apart from the previous trastuzumab administration in adjuvant or neoadjuvant
5) No prior radiotherapy
6) Age 20 to 80 years
7) ECOG PS 0 to 2
8) Expected survival time: more than 3 months
9) LVEF more than 55%
10) Required baseline laboratory parameters
WBC >= 3,500 /mm3 (or Neu >= 1,500 / mm3 ) and <= 12,000mm3
Plt >= 100,000/mm3
Hb >= 9.0g/dl
AST <= 2.5 times ULN and ALT <= 2.5 times ULN
T-Bil <= 1.5mg/dl
Cre <= 1.2mg/dl or Ccr >= 60ml/min (Cockcroft-Gault model)
11) Written informed consent
12) Possible to take orally
Key exclusion criteria
1) Male breast cancer
2) Necessary to continue treatment with warfarin potassium
3) Severe complications [ulcer which needs blood transfusion, uncontrolled diabetes mellitus, interstitial lung disease, pulmonary fibrosis, cerebral thrombosis, cerebral hemorrhage, subarachnoid hemorrhage, ischemia attack, encephalosis, stenocardia, myocardial infarction, uncontrolled congestive heart failure or arrhythmia, intestinal tract paralysis, ileus, neurodegeneration disease, hepatic insufficiency, cirrhosis, renal insufficiency]
4) Active double cancer
5) Inflammatory breast cancer or symptomatic brain metastasis
6) Patients who have only the lesion which caught the radiation exposure
7) Patients who received previous treatment with oral fluoropyrimidines within 12 months
8) internal use of flucytosyne
9) doctors decision for excluion
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Horiguchi |
Organization
Gunma University Graduate School of Medicine
Division name
Thoracic Visceral Organ Surgery
Zip code
Address
3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Horiguchi |
Organization
Gunma Breast Clinical Conference Study Group(GBCCSG)
Division name
Secretariat Division (Department of Thoracic Visceral Organ Surgery , Gunma University Graduate Scho
Zip code
Address
3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan
TEL
Homepage URL
Sponsor or person
Institute
Gunma Breast Clinical Conference Study Group(GBCCSG)
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2008 | Year | 10 | Month | 01 | 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
| 2008 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | 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
| 2008 | Year | 10 | Month | 01 | Day |
Last modified on
| 2013 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001640
