Study of Aspirin and Exemestane as Adjuvant Treatment in Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Phase 2 Study of Aspirin Plus Exemestane Comparing With Exemestane Alone in the Adjuvant Treatment of Postmenopausal Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01431053
• Other study ID #: CH-BC-011
• Status: Recruiting
• Phase: Phase 2
• First received: September 7, 2011
• Last updated: March 12, 2013
• Start date: July 2011
• Est. completion date: July 2014

Study information

• Verified date: March 2013
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan, M.D.
• Phone: 86-135 0127 0834
• Email: yuanpeng01[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Breast cancer after surgery postmenopausal

Exclusion Criteria:

• contraindication of aspirin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• aspirin
Aspirin 50mg po daily
• Exemestane
Exemestane 25mg po daily

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life		4 years	Yes