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Study of Aspirin and Exemestane as Adjuvant Treatment in Breast Cancer

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ClinicalTrials.gov Identifier: NCT01431053
Recruitment Status : Unknown
Verified March 2013 by Peng Yuan, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 9, 2011
Last Update Posted : March 13, 2013
Sponsor:
Information provided by (Responsible Party):
Peng Yuan, Chinese Academy of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: aspirin Drug: Exemestane Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2011
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Exemestane + Aspirin Drug: aspirin
Aspirin 50mg po daily
Drug: Exemestane
Exemestane 25mg po daily
Active Comparator: Exemestane Drug: Exemestane
Exemestane 25mg po daily



Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer after surgery postmenopausal

Exclusion Criteria:

  • contraindication of aspirin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aspirin
Exemestane
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
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists