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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003699
Receipt No. R000004481
Scientific Title Evaluation of the usefulness of letrozole as neoadjuvant hormone therapy for postmenopausal patients with hormone receptor-positive breast cancer
Date of disclosure of the study information 2010/06/03
Last modified on 2018/08/03

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Basic information
Public title Evaluation of the usefulness of letrozole as neoadjuvant hormone therapy for postmenopausal patients with hormone receptor-positive breast cancer
Acronym Evaluation of the usefulness of letrozole as neoadjuvant hormone therapy for postmenopausal patients with hormone receptor-positive breast cancer
Scientific Title Evaluation of the usefulness of letrozole as neoadjuvant hormone therapy for postmenopausal patients with hormone receptor-positive breast cancer
Scientific Title:Acronym Evaluation of the usefulness of letrozole as neoadjuvant hormone therapy for 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 The efficacy and safety will be evaluated that letrozole is administered to postmenopausal 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 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 Postmenopausal women with invasive breast cancer who meet the following inclusion criteria.
(1) Patients with a definite diagnosis of invasive breast cancer by core needle biopsy.
(2) Clinical Stage I-IIIA: T1-3N0-1M0 (excluded N2)
(3) Patients who has ER positive tumors (Allred total score (TS) is 3 or moreover) in immunohistochemical staining.
Not concerned with PgR.
(4) HER2 negative by IHC or FISH
(5) Patients who meet one of the following criteria for postmenopause.
(i) Patients aged 60 years and moreover.(ii) Patients aged less than 60 years old with amenorrhea (spontaneous, drug-induced, or hysterectomy-induced menopause) in whom LH or FSH is more than 30 IU/mL or E2 is <20 pg/mL.
(iii) Patients who underwent bilateral oophorectomy.
(6) Subjects must meet all of the following criteria for inclusion in the study.
i) Serum creatinine: <1.5 times the upper limit of the normal range for the medical institution.
ii) AST/ALT: <2.5 times the upper limit of the normal range for the medical institution.
(7) ECOG PS is 0-1.
(8) Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples for investigation.
(9) Patients from written informed consent to participation in the study has been obtained.
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) Synchronous or asynchrous bilateral breast cancer.
(4) Patients with active double cancer.
(5) 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.
(6) Patients within 30 days after completion of treatment with the investigational drugs.
(7) Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Tsugawa
Organization St. Luke's International Hospital
Division name Department of Breast Surgical Oncology
Zip code
Address 9-1, Akashi-cho, Chuo-ku, Tokyo
TEL 03-3541-5151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Tsugawa
Organization St. Luke's International Hospital
Division name Department of Breast Surgical Oncology
Zip code
Address 9-1, Akashi-cho, Chuo-ku, Tokyo
TEL 03-3541-5151
Homepage URL
Email koitsuga@luke.or.jp

Sponsor
Institute St. Luke's International Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004481

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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