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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01277926

Enrollment

Registered

2011-01-17

Start date

2011-04-30

Completion date

2012-12-31

Last updated

2012-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Hormone Receptor Positive, Advanced Breast Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
To assess determinants of treatment choice	12 months	—
To assess the duration of treatment with chemotherapy or endocrine therapy	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

Countries

Brazil

Outcome results