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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01277926
Recruitment Status : Terminated
First Posted : January 17, 2011
Last Update Posted : December 6, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 7 participants
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
Study Start Date : April 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To assess the treatment choice by the medical oncologist for each patient. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To assess determinants of treatment choice [ Time Frame: 12 months ]
  2. To assess the duration of treatment with chemotherapy or endocrine therapy [ Time Frame: 12 months ]
  3. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01277926

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
Study Director: Paulo André Palhares Miranda, Doctor MC Brazil

Responsible Party: AstraZeneca Identifier: NCT01277926     History of Changes
Other Study ID Numbers: NIS-OBR-DUM-2010/1
D6998L00002 ( Other Identifier: AstraZeneca )
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

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