UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000610 |
|---|---|
| Receipt number | R000000738 |
| Scientific Title | Antiestrogen vs aromatase inhibitor after chemotherapy for adjuvant setting: Efficacy of endocrine therapy after chemotherapy in postoperative adjuvant therapy for breast cancer |
| Date of disclosure of the study information | 2007/09/01 |
| Last modified on | 2010/08/25 13:08:27 |
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Basic information
Public title
Antiestrogen vs aromatase inhibitor after chemotherapy for adjuvant setting: Efficacy of endocrine therapy after chemotherapy in postoperative adjuvant therapy for breast cancer
Acronym
Antiestrogen vs aromatase inhibitor after chemotherapy for adjuvant setting: Efficacy of endocrine therapy after chemotherapy in postoperative adjuvant therapy for breast cancer
Scientific Title
Antiestrogen vs aromatase inhibitor after chemotherapy for adjuvant setting: Efficacy of endocrine therapy after chemotherapy in postoperative adjuvant therapy for breast cancer
Scientific Title:Acronym
Antiestrogen vs aromatase inhibitor after chemotherapy for adjuvant setting: Efficacy of endocrine therapy after chemotherapy in postoperative adjuvant therapy for breast cancer
Region
| Japan |
Condition
Condition
Breast cancer patients who have received chemotherapy either before or after surgery are the study subjects
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the benefit of postoperative adjuvant therapy using sequential administration of the hormone, toremifene citrate (TOR) or anastrozole (ANA), after chemotherapy in breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Recurrence-free rate
Key secondary outcomes
- Survival rate.
- Drug adverse events.
- Bone metabolism markers (BAP, NTx).
- BMD (DXA method): Lumbar vertebrae, femoral neck.
- Laboratory values of lipid metabolism (TC, LDL, HDL, Lp(a), TG).
- Compliance.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fareston (toremifene citrate): 40-mg tablets orally once daily. (For purposes of long-term, no-change evaluation, medication administration will be continued unless definite exacerbation of the clinical condition is observed.)
Interventions/Control_2
Arimidex: 1-mg tablets by mouth once daily. (For purposes of long-term, no-change evaluation, medication administration will be continued unless definite exacerbation of the clinical condition is observed.)
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) Written consent obtained for study participation.
(2) Breast cancer diagnosed histologically with a breast removed or preserved.
(3) Positive ER or PR testing by immunohistochemistry (IHC), enzyme immunoassay (EIA) and who meet the criteria of each institution.
(4) HER2 evaluation.
(5) Patient Status (PS): 0 or 1.
(6) Fully functional heart, liver, kidneys, and bone marrow.
(7) More than one year since last menstruation or tested postmenopausal from estradiol (E2) and follicle-stimulating hormone (FSH) levels based on evaluation standard of each institution.
(8) Expected to live for at least three months (or longer) after study commencement.
Key exclusion criteria
(1) Pregnant or breast feeding.
(2) Bilateral or inflammatory breast cancer.
(3) Multiple cancers.
(4) Life-threatening metastases.
(5) History of serious hypersensitivity.
(6) Judged ineligible for the study by the study doctor.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru, IWASE |
Organization
University of Tokyo Hospital
Division name
Department of Palliative Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411(ext.37417)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yujiro, KURODA |
Organization
University of Tokyo Hospital
Division name
Department of Palliative Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
03-5800-9084
Homepage URL
kurodasan@gmail.com
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
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00437359
Org. issuing International ID_1
ClinicalTrials.gov
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 | 09 | Month | 01 | 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
| 2007 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 02 | Month | 13 | Day |
Last modified on
| 2010 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000738
