Back to resultsStudy of Aspirin and Exemestane as Adjuvant Treatment in Breast Cancer
Primary Purpose
Breast Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
aspirin
Exemestane
Sponsored by
About this trial
This is an interventional prevention trial for Breast Neoplasms focused on measuring exemestane, aspirin, quality of life
Eligibility Criteria
Inclusion Criteria:
- Breast cancer after surgery postmenopausal
Exclusion Criteria:
- contraindication of aspirin
Sites / Locations
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exemestane + Aspirin
Exemestane
Arm Description
Outcomes
Primary Outcome Measures
Quality of Life
Secondary Outcome Measures
Full Information
NCT ID
NCT01431053
First Posted
September 7, 2011
Last Updated
March 12, 2013
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01431053
Brief Title
Study of Aspirin and Exemestane as Adjuvant Treatment in Breast Cancer
Official Title
Phase 2 Study of Aspirin Plus Exemestane Comparing With Exemestane Alone in the Adjuvant Treatment of Postmenopausal Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase II study to assess efficacy/safety of Exemestane with or without Aspirin as the adjuvant treatment in postmenopausal breast cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
exemestane, aspirin, quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exemestane + Aspirin
Arm Type
Experimental
Arm Title
Exemestane
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
aspirin
Intervention Description
Aspirin 50mg po daily
Intervention Type
Drug
Intervention Name(s)
Exemestane
Intervention Description
Exemestane 25mg po daily
Primary Outcome Measure Information:
Title
Quality of Life
Time Frame
4 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Breast cancer after surgery postmenopausal
Exclusion Criteria:
contraindication of aspirin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Yuan, M.D.
Phone
86-135 0127 0834
Email
yuanpeng01@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Yuan, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Yuan, M.D.
Phone
86-135 0127 0834
Email
yuanpeng01@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Study of Aspirin and Exemestane as Adjuvant Treatment in Breast Cancer
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