UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004345 |
|---|---|
| Receipt number | R000005201 |
| Scientific Title | Phase II clinical trial of the combination of high-dose toremifene and exemestane for advanced/recurrent breast cancer unresponsive to nonsteroidal aromatase inhibitors |
| Date of disclosure of the study information | 2010/10/07 |
| Last modified on | 2015/07/28 09:48:28 |
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Basic information
Public title
Phase II clinical trial of the combination of high-dose toremifene and exemestane for advanced/recurrent breast cancer unresponsive to nonsteroidal aromatase inhibitors
Acronym
Phase II clinical trial of the combination of high-dose toremifene and exemestane for advanced/recurrent breast cancer unresponsive to nonsteroidal aromatase inhibitors
Scientific Title
Phase II clinical trial of the combination of high-dose toremifene and exemestane for advanced/recurrent breast cancer unresponsive to nonsteroidal aromatase inhibitors
Scientific Title:Acronym
Phase II clinical trial of the combination of high-dose toremifene and exemestane for advanced/recurrent breast cancer unresponsive to nonsteroidal aromatase inhibitors
Region
| Japan |
Condition
Condition
Advanced/recurrent breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We confirmed the effectiveness and safety of combination therapy with 120 mg of toremifene citrate and exemestane in patients with postmenopausal breast cancer who showed recurrence during or after nonsteroidal aromatase inhibitors as postoperative adjunctive therapy or therapy for recurrence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical benefit
Key secondary outcomes
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
Daily oral administration of 120 mg (60 mg x 2 tablets) of toremifene and 25 mg/day of exemestane
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. Patients who provided written informed consent by themselves in principle to participate in this trial
2. Postmenopausal females with breast cancer in whom the primary lesion was confirmed to be breast cancer by histological or cytological examination
3. Patients who showed recurrence during or after the administration of anastrozole or letrozole as postoperative adjunctive therapy or therapy for progression/recurrence
4. Patients not using other endocrine therapy or chemotherapy drugs after the completion of aromatase inhibitor administration
5. Patients with a lesion allowing measurement or only bone metastasis
6. ER(+) and/or PgR(+) patients
7. Patients expected to survive for 3 months or more
8. Patients with a performance status (ECOG) of 0, 1, or 2 9. Patients with adequately maintained heart/liver/kidney/bone marrow functions and fulfilling the following conditions
(1) Hb level:  9g/d
(2) AST(GOT), ALT(GPT):  2.5 times the normal limit at the institution
Key exclusion criteria
1. Patients with active double cancer
2. Patients with life-threatening symptoms, extensive organ metastasis (1/3 of the organ), or brain metastasis
3. Patients with a past history of severe drug hypersensitivity
4. Pregnant or breastfeeding females
5. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Sakaguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Endocrine & Breast Surgery
Zip code
Address
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto Prefectural University of Medicine
Division name
Endocrine & Breast Surgery
Zip code
Address
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
Homepage URL
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
| 2010 | Year | 10 | Month | 07 | 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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2015 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005201
