Study of Aspirin and Exemestane as Adjuvant Treatment in Breast Cancer

NCT ID: NCT01431053

Last Updated: 2013-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exemestane + Aspirin

Group Type EXPERIMENTAL

aspirin

Intervention Type DRUG

Aspirin 50mg po daily

Exemestane

Intervention Type DRUG

Exemestane 25mg po daily

Exemestane

Group Type ACTIVE_COMPARATOR

Exemestane

Intervention Type DRUG

Exemestane 25mg po daily

Interventions

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aspirin

Aspirin 50mg po daily

Intervention Type DRUG

Exemestane

Exemestane 25mg po daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Breast cancer after surgery postmenopausal

Exclusion Criteria

* contraindication of aspirin
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Peng Yuan

Associate Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peng Yuan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng Yuan, M.D.

Role: CONTACT

86-135 0127 0834

Facility Contacts

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Peng Yuan, M.D.

Role: primary

86-135 0127 0834

Other Identifiers

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CH-BC-011

Identifier Type: -

Identifier Source: org_study_id

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