NCT01208779

Brief Summary

This observational study in estrogen receptor positive early breast cancer patients is aimed to evaluate the patients' compliance to aromatase inhibitor (AI) therapy and to collect country-specific data in estrogen receptor positive early breast cancer patients including data on demography, disease characteristics and disease management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

September 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 17, 2013

Status Verified

July 1, 2013

Enrollment Period

1.8 years

First QC Date

September 23, 2010

Last Update Submit

July 16, 2013

Conditions

Hormon Receptor Positive Breast Cancer

Keywords

ComplianceHR+ breast cancerepidemiology

Outcome Measures

Primary Outcomes (1)

  • Evaluate compliance rate, as assessed by investigator, after 12 months from baseline.

    12 months

Secondary Outcomes (6)

  • Evaluate compliance rate, assessed by investigator, after 6 months of follow up

    12 months

  • Evaluate the extent of patient educational activities as assessed by patient (using patient questionnaire) after 6 and 12 months

    12 months

  • Evaluate patient compliance as assessed by the patient (using patient questionnaire) after 6 and 12 months

    12 months

  • Collect epidemiology data; Demographic data: age, height, weight, lifestyle, menarche, childbirth, lactation, menopausal status

    12 months

  • Primary disease (breast cancer) characteristics: receptor status, disease stage

    12 months

  • +1 more secondary outcomes

Study Arms (1)

1

Women with estrogen receptor positive breast cancer already receiving treatment with an aromatase inhibitor (AI) will be enrolled in the study

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Oncology centers

You may qualify if:

  • Postmenopausal females with estrogen receptor positive breast cancer that are currently treated with aromatase inhibitor (AI) medication
  • Provision of subject informed consent

You may not qualify if:

  • If participating in any clinical trial, the subject cannot take part in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Vojvodina, Sremska Kamenica, Serbia

Location

Research Site

Belgrade, Serbia

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Dr Jasna Pesic

    M.D.spec of oncology, Institute for oncology Vojvodina, Sremska Kamenica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2010

First Posted

September 24, 2010

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

July 17, 2013

Record last verified: 2013-07

Locations

SE(2)