UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000802 |
|---|---|
| Receipt number | R000000961 |
| Scientific Title | Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-10) |
| Date of disclosure of the study information | 2007/08/18 |
| Last modified on | 2017/11/30 18:03:01 |
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Basic information
Public title
Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-10)
Acronym
Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-10)
Scientific Title
Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-10)
Scientific Title:Acronym
Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-10)
Region
| Japan |
Condition
Condition
Postmenopausal breast cancer
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endocrine-sensitive postmenopausal breast cancer patients (60 years of age and over) received preoperative exemestane therapy, and time to progression was assessed as the primary endpoint, and maximum response time, tumor regression rate, pathologic antitumor effect, cell proliferation capacity, TTF, proportion who were able to avoid surgery during the 3 years after the start of treatment, adverse events, and bone mineral density as secondary endpoints.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Time To Progression
Key secondary outcomes
1.Maximum efficacy period
2.Rate of tumor reduction
3.Relationship between pathological response rate and capacity of cell proliferation, activity of aromatase and functional analysis of estrogen receptor of breast cancer cells
4.Time To Treatment Failure
5.Adverse events
6.Changes in bone mineral density
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
Exemestane (25 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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Patients diagnosed histologically as having had invasive ductal carcinoma.
2.Patients 60 years or more, at least one of the following features;
A.One year have passed since the final menstruation
B.Past history of surgical bilateral ovariectomy (including radiotherapy)
C.Past history of hysterectomy and the serum levels of FSH, LH, and E2 are postmenopausal levels
3.StageIIA-IIIB
4.ER-positive and HER2-negative defined with immunohistochemical staining
5.PS(WHO):0-1
6.Patients who satisfy the reference levels of blood cell count and biochemical examination at the institutions
7.Benefit is expected to be obtained from the initial systemic treatment
8.A written consent is obtained
Key exclusion criteria
1.Patients under chemotherapy and hormone therapy (for tumors)
2.Patients under treatment with the drugs (including HRT) that may influence on the conditions of sex hormone
3.Patients with a past history of breast cancer or with double cancer
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Tabei |
Organization
Saitama Cancer Center
Division name
Breast and Medical Oncology
Zip code
Address
818 Komuro Ina Kitaadachi, Saitama 362-0806
TEL
048-722-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Kai |
Organization
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name
Executive office(c/o: Shin-toshin Ladies' Clinic)
Zip code
Address
3F, Capital Bldg. 4-261-1, Kishiki-cho, Omiya-ku, Saitama-City 330-0843, Saitama Prefecture
TEL
048-600-1722
Homepage URL
http://www.sbccsg.org/
toshikai@nyc.odn.ne.jp
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department
Personal name
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
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 | 08 | Month | 18 | 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
| 2007 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | 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 | 08 | Month | 17 | Day |
Last modified on
| 2017 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000961
