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

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT01277926
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Study Start: 2011-04
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the treatment choice by the medical oncologist for each patient.	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇧🇷 Ribeirao Preto, Brazil