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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000966
Receipt No. R000001163
Scientific Title Evaluation of the usefulness of letrozole as hormone therapy for postmenopausal patients with Ductal Carcinoma In Situ (DCIS)
Date of disclosure of the study information 2008/01/04
Last modified on 2012/01/10

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Basic information
Public title Evaluation of the usefulness of letrozole as hormone therapy for postmenopausal patients with Ductal Carcinoma In Situ (DCIS)
Acronym Evaluation of the usefulness of letrozole as hormone therapy for postmenopausal patients with Ductal Carcinoma In Situ (DCIS)
Scientific Title Evaluation of the usefulness of letrozole as hormone therapy for postmenopausal patients with Ductal Carcinoma In Situ (DCIS)
Scientific Title:Acronym Evaluation of the usefulness of letrozole as hormone therapy for postmenopausal patients with Ductal Carcinoma In Situ (DCIS)
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The efficacy and safety will be evaluated that letrozole is administered alone to postmenopausal patients with DCIS
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Objective response
Key secondary outcomes Clinical usefulness
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 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 DCIS who meet the following inclusion criteria.
(1) Patients with a definite diagnosis of DCIS by core needle biopsy.
To exclude the possibility of invasive carcinoma, it will be confirmed by ultrasound that no lumps are formed.
(2) Patients who has ER positive tumors (Allred total score (TS) 3) in immunohistochemical staining.
Not concerned with PgR.
(3) Patients who meet one of the following criteria for postmenopause.
(i) Patients aged 55 years and moreover, at 1 year after the last menstruation.
(ii) Patients aged <55 years with amenorrhea (spontaneous, drug-induced, or hysterectomy-induced menopause) in whom LH or FSH is &#61619;30 IU/mL or E2 is <20 pg/mL.
(iii) Patients who underwent bilateral oophorectomy.
(iv) Patients who have had amenorrhea for &#61619;3 months because of loss of ovarian function due to radiotherapy.
(5) Patients without previous treatment for DCIS.
(6) Patients with bone marrow, renal, and hepatic functions which are adequate to evaluate the safety of the study drug accurately.
WBC: >3,500/mm3
Hemoglobin: >11.0 g/dL
Platelet count: >10.0 x100000/mm3
Serum creatinine: <1.5 times the upper limit of the normal range for the medical institution
Total bilirubin: <1.5 times the upper limit of the normal range for the medical institution
AST/ALT: <2.5 times the upper limit of the normal range for the medical institution.
(7)Patients with performance status (ECOG Performance Status: PS) 0-1.
(8)Patients who can provide biopsy tissue specimens, isolated tissues, and blood samples for investigation.
(9)Patients from whom written informed consent to participation in the study has been obtained.
Key exclusion criteria (1)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.)
(2)Patients with bilateral DCIS.
(3)Patients within 30 days after completion of treatment with the investigational drugs.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seigo Nakamura
Organization St. Luke's International Hospital
Division name 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 Takashi Kuwayama
Organization St. Luke's International Hospital
Division name Breast Surgical Oncology
Zip code
Address 9-1,Akashi-cho,Chuo-ku,Tokyo
TEL 03-3541-5151
Homepage URL
Email kuwayama-bc@umin.ac.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 聖路加国際病院

Other administrative information
Date of disclosure of the study information
2008 Year 01 Month 04 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 No longer recruiting
Date of protocol fixation
2006 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2008 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
2008 Year 01 Month 04 Day
Last modified on
2012 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001163

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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