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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01277926
First received: January 12, 2011
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Patterns of Care in Hormone-Receptor Positive, Advanced Breast Cancer in Brazil: A Prospective, Observational Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the treatment choice by the medical oncologist for each patient. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess determinants of treatment choice [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To assess the duration of treatment with chemotherapy or endocrine therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To evaluate the rate of treatment continuation at 6 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assess the profile of adverse events with each treatment modality and assess patient participation and understanding in treatment choice


Enrollment: 7
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

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

Primary care clinic

Criteria

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.
  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 ClinicalTrials.gov identifier: NCT01277926

Locations
Brazil
Research Site
Rio de Janeiro, RJ, Brazil
Research Site
Porto Alegre, RS, Brazil
Research Site
Sao Paulo, SP, Brazil
Research Site
Belo Horizonte, Brazil
Research Site
Mogi das Cruzes, Brazil
Research Site
Ribeirao Preto, Brazil
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paulo André Palhares Miranda, Doctor MC Brazil
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01277926     History of Changes
Other Study ID Numbers: NIS-OBR-DUM-2010/1, D6998L00002
Study First Received: January 12, 2011
Last Updated: December 5, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by AstraZeneca:
Breast Cancer
Hormone Receptor Positive, Advanced Breast Cancer

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

ClinicalTrials.gov processed this record on October 02, 2014