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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003101
Receipt No. 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

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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
Email

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
Email tasuzuki-endo@umin.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003765

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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