Patterns of Care in Hormone-receptor Positive, Advanced Breast Cancer

December 5, 2012 updated by: AstraZeneca

Patterns of Care in Hormone-Receptor Positive, Advanced Breast Cancer in Brazil: A Prospective, Observational Study

The purpose of this study is to characterize the current patterns of care for patients with hormone-receptor-positive, advanced breast cancer who have failed one prior endocrine therapy in Brazil. To investigate patient-related, disease-related and physician-related characteristics that correlate with the use of either endocrine treatment or chemotherapy in such patients. And to evaluate patients' understanding of the treatment options and their participation in the choice.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte, Brazil
        • Research Site
      • Mogi das Cruzes, Brazil
        • Research Site
      • Ribeirao Preto, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • RS
      • Porto Alegre, RS, Brazil
        • Research Site
    • SP
      • Sao Paulo, SP, Brazil
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • Histological or cytological diagnosis of breast cancer

  • Postmenopausal status at the time of enrolment, according to the following definitions:

    • History of bilateral oophorectomy at any age
    • Proven hormonal menopause
  • Positive estrogen receptor (ER) and/or progesterone receptor (PR) by immuno
  • Failure of one previous endocrine therapy in the adjuvant or metastatic setting
  • Use of no more than one previous chemotherapy regimen in the neoadjuvant or adjuvant setting
  • Indication to receive chemotherapy or endocrine therapy

Exclusion Criteria:

  • Inability to comply with the study protocol
  • Use of more than one previous endocrine therapy, regardless of the setting; -- Previous use of chemotherapy for metastatic disease
  • Use of neoadjuvant endocrine therapy as the only previous type of endocrine therapy
  • Serious medical, surgical or psychiatric comorbidity that, upon investigator's discretion, should preclude participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the treatment choice by the medical oncologist for each patient.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess determinants of treatment choice
Time Frame: 12 months
12 months
To assess the duration of treatment with chemotherapy or endocrine therapy
Time Frame: 12 months
12 months
To evaluate the rate of treatment continuation at 6 months
Time Frame: 12 months
Assess the profile of adverse events with each treatment modality and assess patient participation and understanding in treatment choice
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Paulo André Palhares Miranda, Doctor, MC Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

January 12, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OBR-DUM-2010/1
  • D6998L00002 (Other Identifier: AstraZeneca)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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