UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004726 |
|---|---|
| Receipt number | R000005532 |
| Scientific Title | Preoperative Short term endocrine therapy for hormonal receptor positive breast cancer |
| Date of disclosure of the study information | 2010/12/15 |
| Last modified on | 2012/01/13 15:16:11 |
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Basic information
Public title
Preoperative Short term endocrine therapy for hormonal receptor positive breast cancer
Acronym
Preste trial
Scientific Title
Preoperative Short term endocrine therapy for hormonal receptor positive breast cancer
Scientific Title:Acronym
Preste trial
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to validate the efficacy of short-term neoadjuvant endocrine therapy and to investigate the predictive factors of endocrine therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
disease free survival
Key secondary outcomes
Clinical usefulness
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 (tamoxifen for premenopausal patients or letrozole for postmenopausal patients)
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Histologically confirmed invasive ductal carcinoma
2. Estrogen receptor and/or progesterone receptor positive
3. No previous treatment for the breast cancer
4. Subjects must meet all of the following criteria for inclusion in the study.
1) AST/ALT: <2 times the upper limit of the normal range
2) Serum creatinine: <1.5 times the upper limit of the normal range
5. ECOG PS of 0-2.
6. Patients from written informed consent to participation in the study has been obtained
Key exclusion criteria
1. During pregnancy or lactation
2. With active other cancer
3. History of drug allergy
4. Significant illness that might influence the tolerability of treatment (interstitual pneumonia or lung fibrosis, myocardial infarction or congestive heart failure at the past history, or patients who need treatment of ischemic heart disease, arryhythmia or vascular disorder)
5. Severe myelosuppression
6. Severe kidney failure or liver failure
7. Active infectious disease
8. Inflammatory or bilateral breast cancer
9. Patients whom doctors judged inadequate to the enrollment of this study by other reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Jinno |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi Shinjuku Tokyo 1608582 JAPAN
TEL
+813-33531211ext.62334
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Jinno |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi Shinjuku Tokyo 1608582 JAPAN
TEL
+813-33531211ext.62334
Homepage URL
jinno@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 15 | Day |
Last modified on
| 2012 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005532
| Research Plan | |
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| 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 |
