UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000881 |
|---|---|
| Receipt number | 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 07:47:01 |
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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
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
tanakaka@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Breast and Thyroid Surgery, Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001062
