NCT01431053

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2013

Enrollment Period

3 years

First QC Date

September 7, 2011

Last Update Submit

March 12, 2013

Conditions

Breast Neoplasms

Keywords

exemestaneaspirinquality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    4 years

Study Arms (2)

Exemestane + Aspirin

EXPERIMENTAL
Drug: aspirinDrug: Exemestane

Exemestane

ACTIVE COMPARATOR
Drug: Exemestane

Interventions

aspirinDRUG

Aspirin 50mg po daily

Exemestane + Aspirin
ExemestaneDRUG

Exemestane 25mg po daily

ExemestaneExemestane + Aspirin

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer after surgery postmenopausal

You may not qualify if:

  • contraindication of aspirin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Aspirinexemestane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Peng Yuan, M.D.

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan, M.D.

CONTACT

86-135 0127 0834yuanpeng01@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 9, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 13, 2013

Record last verified: 2013-03

Locations

CN(1)