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Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01208779
First received: September 23, 2010
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition
Hormon Receptor Positive Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Epidemiological, Non-interventional Study to Evaluate Patient Compliance in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Evaluate compliance rate, as assessed by investigator, after 12 months from baseline. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate compliance rate, assessed by investigator, after 6 months of follow up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evaluate the extent of patient educational activities as assessed by patient (using patient questionnaire) after 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evaluate patient compliance as assessed by the patient (using patient questionnaire) after 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Collect epidemiology data; Demographic data: age, height, weight, lifestyle, menarche, childbirth, lactation, menopausal status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Primary disease (breast cancer) characteristics: receptor status, disease stage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Disease management data: treatment/treatment changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Women with estrogen receptor positive breast cancer already receiving treatment with an aromatase inhibitor (AI) will be enrolled in the study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Oncology centers

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • If participating in any clinical trial, the subject cannot take part in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208779

Locations
Serbia
Research Site
Vojvodina, Sremska Kamenica, Serbia
Research Site
Belgrade, Serbia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dr Jasna Pesic M.D.spec of oncology, Institute for oncology Vojvodina, Sremska Kamenica
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01208779     History of Changes
Other Study ID Numbers: NIS-ORS-DUM-2010/1
Study First Received: September 23, 2010
Last Updated: January 31, 2012
Health Authority: Serbia: Ethics Committee

Keywords provided by AstraZeneca:
Compliance
HR+ breast cancer
epidemiology

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013