Study of Aspirin and Exemestane as Adjuvant Treatment in Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Peng Yuan, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01431053
First received: September 7, 2011
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Drug: aspirin
Drug: Exemestane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 2 Study of Aspirin Plus Exemestane Comparing With Exemestane Alone in the Adjuvant Treatment of Postmenopausal Breast Cancer

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exemestane + Aspirin Drug: aspirin
Aspirin 50mg po daily
Drug: Exemestane
Exemestane 25mg po daily
Active Comparator: Exemestane Drug: Exemestane
Exemestane 25mg po daily

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer after surgery postmenopausal

Exclusion Criteria:

  • contraindication of aspirin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431053

Contacts
Contact: Peng Yuan, M.D. 86-135 0127 0834 yuanpeng01@hotmail.com

Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Peng Yuan, M.D.    86-135 0127 0834    yuanpeng01@hotmail.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Peng Yuan, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Peng Yuan, Associate Chief Physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01431053     History of Changes
Other Study ID Numbers: CH-BC-011
Study First Received: September 7, 2011
Last Updated: March 12, 2013
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Medical Sciences:
exemestane
aspirin
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Aspirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014