Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 23, 2010
Last updated: July 16, 2013
Last verified: July 2013
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.

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:

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 ]

Secondary Outcome Measures:
  • Evaluate compliance rate, assessed by investigator, after 6 months of follow up [ Time Frame: 12 months ]
  • Evaluate the extent of patient educational activities as assessed by patient (using patient questionnaire) after 6 and 12 months [ Time Frame: 12 months ]
  • Evaluate patient compliance as assessed by the patient (using patient questionnaire) after 6 and 12 months [ Time Frame: 12 months ]
  • Collect epidemiology data; Demographic data: age, height, weight, lifestyle, menarche, childbirth, lactation, menopausal status [ Time Frame: 12 months ]
  • Primary disease (breast cancer) characteristics: receptor status, disease stage [ Time Frame: 12 months ]
  • Disease management data: treatment/treatment changes [ Time Frame: 12 months ]

Enrollment: 90
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Women with estrogen receptor positive breast cancer already receiving treatment with an aromatase inhibitor (AI) will be enrolled in the study


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Oncology centers

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01208779

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

Responsible Party: AstraZeneca Identifier: NCT01208779     History of Changes
Other Study ID Numbers: NIS-ORS-DUM-2010/1
Study First Received: September 23, 2010
Last Updated: July 16, 2013

Keywords provided by AstraZeneca:
HR+ breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017