UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006286 |
|---|---|
| Receipt number | R000007440 |
| Scientific Title | Randomized study of tamoxifen versus goserelin acetate vs combination as preoperative endocrine therapy for estrogen receptor positive pre-menopausal patients. |
| Date of disclosure of the study information | 2011/09/05 |
| Last modified on | 2015/03/13 11:35:14 |
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Basic information
Public title
Randomized study of tamoxifen versus goserelin acetate vs combination as preoperative endocrine therapy for estrogen receptor positive pre-menopausal patients.
Acronym
Randomized study of tamoxifen versus goserelin acetate versus combination as preoperative endocrine therapy.
Scientific Title
Randomized study of tamoxifen versus goserelin acetate vs combination as preoperative endocrine therapy for estrogen receptor positive pre-menopausal patients.
Scientific Title:Acronym
Randomized study of tamoxifen versus goserelin acetate versus combination as preoperative endocrine therapy.
Region
| Japan |
Condition
Condition
Estrogen receptor positive, pre-menopausal breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To compare the efficacy and safety of tamoxifen and goserelin acetate and combination as preoperative endocrine therapy for pre-menopausal patients. To find the patients who gain the benefit from each treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Suppression of Ki-67
Key secondary outcomes
Safety
Response rate
Histopathological response
Predictive factor
Relapse-free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: tamoxifen
Administration of 20mg tamoxifen daily for 8 weeks (day1-56)
Interventions/Control_2
Group B: goserelin acetate
Subcutaneous injection of goserelin acetate each 4 weeks for 8 weeks (day 1,28)
Interventions/Control_3
Group C: tamoxifen + goserelin acetate
1)Administration of 20mg tamoxifen daily for 8 weeks (day1-56)
2)Subcutaneous injection of goserelin acetate each 4 weeks for 8weeks (day 1,28)
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
| 30 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
1) Invasive breast cancer in pathological examination
2) 30 to 55 years old women who was comformed menstruation in recent 3 months
3) T1-2,N0,M0 in TNM classification
4) No previous chemotherapy, radiation, endocrine therapy, immunotherapy
5) Existance of measurable lesion
6)ER and/or PgR positive(IHC >10%)
7)HER2 negative
8)Performance Status 0-1
9)Sustained major organ funcrion
WBC >= 3,000/mm3,<=12,000/mm3
Netrophil >= 2,000/mm3
PLT >= 10x10 4/mm3
Hb >= 8.0 g/dl
AST(GOT),ALT(GPT)<=facility standard value x 1.5
T.Bili <=facility standard value x 1.25
Cre <= facility standard value x 1.5
Normal in electrocardiogram
10)Written informe consent
Key exclusion criteria
1) hypersensitivity to test drug
2) serious complication (malignant hypertention, congestive heart failure, coronary failure, cardiac infarction in last 6 month, arhythmia which need treatment, infection disease, bleeding tendency, etc.)
3) Patients who administrate anticlotting drug or SSRI
4)Patinent who have double cancer
5)Ductal carcinoma in situ or inflamatory breast cancer
6) Bilateral breast cancer, male breast cancer
7) Pregnant women, breat-feeding mother, possibility of pregnancy
8) History of thrombosis
9) History of mental disease or under medical treatment.
10)Patient regarded as inadequate by responsible doctor
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Shimizu |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Breast Surgery
Zip code
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama City, 231-8682, Japan
TEL
045-628-6100
d-shimizu.surg@yokohama.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Shimizu |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Breast Surgery
Zip code
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama City, 231-8682, Japan
TEL
045-628-6100
Homepage URL
d-shimizu.surg@yokohama.jrc.or.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
横浜市立大学附属市民総合医療センター（神奈川県）
聖マリアンナ医科大学医学部乳腺外科（神奈川県）
北里大学医学部乳腺外科（神奈川県）
東海大学医学部乳腺外科（神奈川県）
横浜市立大学医学部臨床腫瘍科乳腺外科（神奈川県）
神奈川県立がんセンター（神奈川県）
湘南記念病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 05 | 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
| 2011 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2011 | Year | 09 | Month | 05 | Day |
Last modified on
| 2015 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007440
