UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003700 |
|---|---|
| Receipt number | R000004482 |
| Scientific Title | Evaluation of the usefulness and safety of goserelin plus tamoxifen as neoadjuvant hormone therapy for premenopausal patients with hormone receptor-positive breast cancer |
| Date of disclosure of the study information | 2010/06/03 |
| Last modified on | 2018/08/03 11:05:38 |
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Basic information
Public title
Evaluation of the usefulness and safety of goserelin plus tamoxifen as neoadjuvant hormone therapy for premenopausal patients with hormone receptor-positive breast cancer
Acronym
Evaluation of the usefulness and safety of goserelin plus tamoxifen as neoadjuvant hormone therapy for premenopausal patients with hormone receptor-positive breast cancer
Scientific Title
Evaluation of the usefulness and safety of goserelin plus tamoxifen as neoadjuvant hormone therapy for premenopausal patients with hormone receptor-positive breast cancer
Scientific Title:Acronym
Evaluation of the usefulness and safety of goserelin plus tamoxifen as neoadjuvant hormone therapy for premenopausal patients with hormone receptor-positive breast cancer
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 efficacy and safety will be evaluated that goserelin plus tamoxifen is administered to premenopausal patients with hormone receptor-positive invasive breast cancer. The utility of measuring Ki67 for time will be evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Clinical response
Key secondary outcomes
Pathological response
Safety
Clinical usefulness
Changing of Ki67-score
Disease Free Survival
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
Neoadjuvant endocrine therapy (goserelin + tamoxifen)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Premenopausal women with invasive breast cancer who meet the following inclusion criteria.
(1) Clinical Stage I-IIB: T1-3N0M0
(2) Patients with a definite diagnosis of invasive breast cancer by core needle biopsy.
(3) Patients who meet one of the following criteria for premenopause.
(i) Periodic menstruation bleeding.
(ii) Patients with amenorrhea in whom LH or FSH is <30 IU/mL and E2 is >10 pg/mL.
(4) Patients who has ER positive tumors (Allred total score (TS) is 3 or moreover) in immunohistochemical staining. Not concerned with PgR.
(5) HER2 negative by IHC or FISH
(6) Patients with bone marrow, renal, and hepatic functions which are adequate to evaluate the safety of the study drug accurately.
WBC: >3,000/mm3
Hemoglobin: >9.0 g/dL
Platelet count: >10.0 x10000/mm3
AST/ALT: <1.5times the upper limit of the normal range for the medical institution.
Serum creatinine: <1.25 times the upper limit of the normal range for the medical institution.
(7) ECOG PS is 0-2.
(8) Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples
Key exclusion criteria
(1) Patients with previous treatment for the breast cancer.
(2) Patients receiving drugs having a potential influence on the status of sex hormones (hormone replacement therapy, raloxifene, etc.). (However, patients after washout for at least 2 months can be enrolled.)
(3) Patients with myocardial infarction or congestive heart failure at the past history, or patients who need treatment of ischemic hear disease, arryhythmia or valvular disorder.
(4) Patients with active double cancer.
(5) Inflammatory breast cancer
(6) Synchronous or asynchrous bilateral breast cancer.
(7) Allergy for radio-enhancer
(8) New test drug
(9) Severe psychosomatic disease
(10) Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Tsugawa, M.D. |
Organization
St. Luke's International Hospital
Division name
Department of Breast Surgical Onocology
Zip code
Address
9-1, Akashi-cho, Chuo-ku, Tokyo
TEL
03-3541-5151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Tsugawa, M.D. |
Organization
St. Luke's International Hospital
Division name
Department of Breast Surgical Onocology
Zip code
Address
9-1, Akashi-cho, Chuo-ku, Tokyo
TEL
03-3541-5151
Homepage URL
koitsuga@luke.or.jp
Sponsor or person
Institute
St. Luke's International Hospital
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
| 2010 | Year | 06 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 03 | Day |
Last modified on
| 2018 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004482
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