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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000881
Receipt No. R000001062
Scientific Title Assessment of the Efficacy of Preoperative Endocrine Therapy of Letrozole in Postmenopausal Patients with Hormone-sensitive Breast cancer of Stage IIA to IIB
Date of disclosure of the study information 2007/11/08
Last modified on 2018/05/18

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Basic information
Public title Assessment of the Efficacy of Preoperative Endocrine Therapy of Letrozole in Postmenopausal Patients with Hormone-sensitive Breast cancer of Stage IIA to IIB
Acronym Assessment of the Efficacy of Preoperative Endocrine Therapy of Letrozole in Postmenopausal Patients with Hormone-sensitive Breast cancer of Stage IIA to IIB
Scientific Title Assessment of the Efficacy of Preoperative Endocrine Therapy of Letrozole in Postmenopausal Patients with Hormone-sensitive Breast cancer of Stage IIA to IIB
Scientific Title:Acronym Assessment of the Efficacy of Preoperative Endocrine Therapy of Letrozole in Postmenopausal Patients with Hormone-sensitive Breast cancer of Stage IIA to IIB
Region
Japan

Condition
Condition Postmenopausal Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the antitumor activity, as measured by clinical tumor response of 16-week treatment with letrozole as preoperative endocrine therapy in untreated postmenopausal hormone receptor positive patients with primary breast cancer of stage IIA-IIB. Breast-conserving surgery will be conducted when the tumor diameter is within 3 cm and the breast-conserving surgery according to the guideline for the breast-conserving surgery is indicated. When the tumor diameter is over 3 cm in patients other than PD, letrozole treatment will be continued for 8 weeks and
antitumor effect will be evaluated in 24 week. Perform of breast-conserving surgery will be reviewed with the tumor diameter of 3 cm as a criterion. Histological effect and safety will also be evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Clinical tumor response rate
Key secondary outcomes 1. Percentage of performing breast- conserving surgery
2.Histological effect in the extensive intraductal component of breast cancer
3.Difference in clinical tumor response effect depending on the expression of HER2
4.Effect for suppressing estradiol concentration in cancer tissues
5.Adverse events

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 Letrozole (2.5 mg Tablet) is internally administered once a day everyday.
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
80 years-old >
Gender Female
Key inclusion criteria 1.Diagnosed histologically as having had invasive breast cancer
2.Postmenopausal women
3.Measurable tumor lesion
4.Clinical stage IIA-IIB
5.ER and/or PgR positive defined with immunohistochemical staining
6.Performance status of 0 to 1
7.Adequate organ function
8.Benefit is expected to be obtained from the preoperative endocrine therapy
9. A written informed consent is obtained
Key exclusion criteria 1.Under chemotherapy and hormone therapy(for tumors)
2.Invasive carcinoma of other organs(less than 5 years after the last treatment)
3.With past history of breast cancer
4.Synchronous bilateral breast cancer
5.Under treatment with the drugs that may influence on the conditions of sex hormone
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Sonoo
Organization Kawasaki Medical School
Division name Department of Breast and Thyroid Surgery
Zip code
Address 577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Email sonoo@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhiro Tanaka
Organization Kawasaki Medical School
Division name Department of Breast and Thyroid Surgery
Zip code
Address 577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email tanakaka@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Breast and Thyroid Surgery, Kawasaki Medical School
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization none

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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
2007 Year 11 Month 08 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
2006 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2010 Year 07 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
2007 Year 11 Month 08 Day
Last modified on
2018 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001062

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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