Study of Aspirin and Exemestane as Adjuvant Treatment in Breast Cancer

March 12, 2013 updated by: Peng Yuan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Breast cancer after surgery postmenopausal

Exclusion Criteria:

  • contraindication of aspirin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ANTICIPATED)

July 1, 2014

Study Completion (ANTICIPATED)

July 1, 2014

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (ESTIMATE)

September 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 13, 2013

Last Update Submitted That Met QC Criteria

March 12, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-BC-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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