UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007014 |
|---|---|
| Receipt number | R000008275 |
| Scientific Title | Investigation of the Efficacy of Pre-operative Endocrine Therapy with Toremifene cirate and Exemestane for Postmenopausal Breast Cancer Patients |
| Date of disclosure of the study information | 2012/01/04 |
| Last modified on | 2012/01/04 18:55:00 |
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Basic information
Public title
Investigation of the Efficacy of Pre-operative Endocrine Therapy with Toremifene cirate and Exemestane for Postmenopausal Breast Cancer Patients
Acronym
Investigation of the Efficacy of Pre-operative Endocrine Therapy with Toremifene cirate and Exemestane for Postmenopausal Breast Cancer Patients
Scientific Title
Investigation of the Efficacy of Pre-operative Endocrine Therapy with Toremifene cirate and Exemestane for Postmenopausal Breast Cancer Patients
Scientific Title:Acronym
Investigation of the Efficacy of Pre-operative Endocrine Therapy with Toremifene cirate and Exemestane for Postmenopausal Breast Cancer Patients
Region
| Japan |
Condition
Condition
Hormone-receptor positive postmenopausal breast cancer patients
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The Study investigates the efficacy of the combination therapy by using two drugs which are dissimilar in action mechanism (total estrogen blockade) as the pre-operative treatment for hormone-receptor positive postmenopausal breast cancer patients. The drusgs used are Toremifene as SERM (Selective estrogen receptor modulator) and Exemestane as AI (Aromatase inhibitor)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Clinical response rate
Key secondary outcomes
Histological therapeutic effect
Rate of breast-conserving surgery
Safety
Change of Ki 6 7, Change of ER/PgR/HER2
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
Tormifene (40mg) and exemestane(25mg) are administered for 16 days continuously prior to the operation
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
1. Brest cancer is histologically confirmed
2. Postmenopausal females
3. The values of E2, LH and FSH show postmenopausal value if the patient's cervical has been resected
4. Measurable lesion including primary lesion
5. Stage II or III (Tumor size is 3 cm or longer)
6. Primary lesion of ER or PgR are positive
7. Performance status 0 -1
8. Pretreatment has not been done to the cancer
9. Operation of breast cancer is scheduled after endocrine therapy
10. No severe complications and each organ functions satisfy the conditions below by the clinical laboratory test
1) WBC more than 4000/mm3 and not more than 10000/mm3, Pl more than 100000/mm3, Hb more than10g/dl
2) T Bil not more than1mg/dl, GOT not more than 60 IU/L, GPT not more than 60 IU/L
11. Written informed consent is obtained
Key exclusion criteria
1. Inflammatory breast cancer
2. Active double cancer
3. Severe heart diseases including myocardial infarction, cardiac insufficiency or patients who have a medical history in these diseases
4. Medical history in deep vein thrombosis
5. Cirrhosis
6. Fever with more than 38 degree
7. Patients who have bleeding tendency
8. Patients who are judged as ineligible for the study enrollment by investigators
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daigo, YAMAMOTO |
Organization
Kansai Medical University Hirakata Hospital
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata 573-1191, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tempei, Miyaji |
Organization
The University of Tokyo
Division name
Interfaculty Initiative in Information Studies
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
Homepage URL
tempeimiyaji@iii.u-tokyo.ac.jp
Sponsor or person
Institute
Japan Breast Cancer Research Network
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
関西医科大学附属枚方病院（大阪府）
東京大学医学部附属病院（東京都）
弘前大学医学部附属病院（青森県）
ナグモクリニック東京院（東京都）
ナグモクリニック福岡院（福岡県）
大慶会 星光病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | 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
| 2012 | Year | 01 | Month | 04 | Day |
Last modified on
| 2012 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008275
