UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025156 |
|---|---|
| Receipt number | R000028938 |
| Scientific Title | Randomized Phase II Study on the Additive Effect of Everolimus in Post-Menopausal Patients with Endocrine Therapy-Sensitive ER-Positive HER2-Negative Metastatic Breast Cancer |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2017/04/26 16:57:40 |
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Basic information
Public title
Randomized Phase II Study on the Additive Effect of Everolimus in Post-Menopausal Patients with Endocrine Therapy-Sensitive ER-Positive HER2-Negative Metastatic Breast Cancer
Acronym
Chloe trial
Scientific Title
Randomized Phase II Study on the Additive Effect of Everolimus in Post-Menopausal Patients with Endocrine Therapy-Sensitive ER-Positive HER2-Negative Metastatic Breast Cancer
Scientific Title:Acronym
Chloe trial
Region
| Japan |
Condition
Condition
Metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether additional administration of everolimus significantly prolongs progression-free survival period in postmenopausal patients with ER-positive HER2negative metastatic breast cancer who have showed a positive response to an aromatase inhibitor (AI) as primary endocrine therapy. To examine the effect on the incidence of adverse events from the additional administration of everolimus to an AI agent.
To explore biomarkers related to the efficacy of everolimus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression-free survival, PFS
Key secondary outcomes
overall survival(OS), response rate (RR), disease control rate (DCR), safety , time to treatment failure (TTF) , the proportion of patients who continued administration of AI agents for 1 year after the randomized allocation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
continued administration of an aromatase inhibitor + everolimus
Interventions/Control_2
continued administration of an aromatase inhibito
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
Postmenopausal patients with ER-positive HER2-negative metastatic breast cancer who maintained SD or better response for 5 months following treatment with aromatase inhibitors as a primary endocrine therapy
Key exclusion criteria
Patients who have active double cancer
Patients who have a history of serious drug hypersensitivity.
Patients who have serious concomitant diseases.
Patients who have an active infectious disease requiring systemic treatment.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadahiko Shien |
Organization
Okayama University Hospital
Division name
Breast and Endocrine Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7265
tshien@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masami Shimazaki |
Organization
CSPOR-BC
Division name
Secretariat
Zip code
Address
2-18-21-101 Kanda, Chiyoda-ku, Tokyo
TEL
03-5294-7288
Homepage URL
http://cspor-bc.or.jp/study/index.html
office-bc@cspor-bc.or.jp
Sponsor or person
Institute
CSPOR-BC
Institute
Department
Personal name
Funding Source
Organization
Reaech founds from the Investigator Initiated-Sponsored Research of the Externally Sponsored Research program of Novartis K.K..
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2017 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | 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
| 2016 | Year | 12 | Month | 06 | Day |
Last modified on
| 2017 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028938
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
