UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003101 |
|---|---|
| Receipt number | R000003765 |
| Scientific Title | Evaluation of efficacy of letrozole as a neoadjuvant endocrine therapy in postmenopausal patients with hormone receptor-positive breast cancer |
| Date of disclosure of the study information | 2010/01/28 |
| Last modified on | 2013/07/29 09:56:58 |
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Basic information
Public title
Evaluation of efficacy of letrozole as a neoadjuvant endocrine therapy in postmenopausal patients with hormone receptor-positive breast cancer
Acronym
Evaluation of efficacy of letrozole as a neoadjuvant endocrine therapy in postmenopausal patients with hormone receptor-positive breast cancer
Scientific Title
Evaluation of efficacy of letrozole as a neoadjuvant endocrine therapy in postmenopausal patients with hormone receptor-positive breast cancer
Scientific Title:Acronym
Evaluation of efficacy of letrozole as a neoadjuvant endocrine therapy in postmenopausal 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
Investigate change in hormone levels and clinical efficacy of preoperative letrozole treatment in postmenopausal patients with hormone receptor-positive breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Sex hormone levels and responsive genes at approximately 12-16 weeks after treatment of letrozole
Key secondary outcomes
Response rate, Pathological response, Safety
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 (Letrozole)
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
1. Patients with noninvasive (including the suspicion) breast carcinoma, which was detected by US etc and diagnosed by biopsy etc, who hope the treatment by breast conserving surgery.
2. The breast carcinoma was positive for estrogen receptor (ER) by immunohistochemistry (more than Allred score 4 or more than 10% of ER-positive cells).
3. Postmenopausal women with breast carcinoma who apply to one or more following criteria.
1) Patients aged more than 60 years.
2) Patients aged less than 60 years old with amenorrhea (more than one year).
3) Patients who underwent bilateral oophorectomy.
*If menopausal status is unclear in patients aged less than 60 years, it is determined by serum FSH and E2 levels.
4. Patients without previous treatment for the breast cancer.
5. ECOG PS is 0-1.
6. 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 for the medical institution.
2) Serum creatinine: <1.5 times the upper limit of the normal range for the medical institution.
7. Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples for investigation.
8. Patients from whom written informed consent to participation in the study has been obtained.
Key exclusion criteria
1. Synchronous or asynchrous bilateral 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 8 weeks can be enrolled.)
3. Patients who are being treated of cerebral infarction at the time of the enrollment.
4. 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.
5. Patients within 30 days after completion of treatment with the investigational drugs.
6. Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Suzuki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Pathology and Histotechnology
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi-ken
TEL
022-717-7947
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Ishida |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi-ken
TEL
022-717-7214
Homepage URL
tasuzuki-endo@umin.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
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
Tohoku University Hospital, KKR Tohoku Kosai Hospital, Miyagi Cancer Center, Ishinomaki Red Cross Hospital, and Nihonkai General Hospital
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 | 01 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | 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
| 2010 | Year | 01 | Month | 27 | Day |
Last modified on
| 2013 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003765
