UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005668 |
|---|---|
| Receipt number | R000006704 |
| Scientific Title | A randomized phase II trial to investigate optimal duration (4 month versus 6 month) of preoperative endocrine therapy |
| Date of disclosure of the study information | 2011/05/30 |
| Last modified on | 2011/05/30 12:14:10 |
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Basic information
Public title
A randomized phase II trial to investigate optimal duration (4 month versus 6 month) of preoperative endocrine therapy
Acronym
PTEX46 Trial
Scientific Title
A randomized phase II trial to investigate optimal duration (4 month versus 6 month) of preoperative endocrine therapy
Scientific Title:Acronym
PTEX46 Trial
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-tumor effect by different 2 treatment duration of neo-exemestane.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical response(caliper)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Four months internal use of aromatase inhibitor (exemestane)
Interventions/Control_2
Six months internal use of aromatase inhibitor (exemestane)
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) postmenopausal women with operable.
2) histologically confirmed, invasive ductal carcinoma
3) Clinical stage II-IIIA
4) ER+ and/or PgR+
5) WHO performance status (PS) 0-1
6) No previous history of breast cancer treatment
7) Informed consent
Key exclusion criteria
1) History of chemotherapy or endocrine therapy for breast cancer.
2) Receiving any drugs that may affect the sex hormone status.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | hojo takashi |
Organization
National Cancer Center Hospital
Division name
department of breast oncology and medical oncology
Zip code
Address
5-1-1 Tsukiji Chuo-ku Tokyo 104-0045 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cancer Center Hospital
Division name
department of breast oncology and medical oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
NO
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
| 2011 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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 | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 30 | Day |
Last modified on
| 2011 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006704
