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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01277926
• Other study ID #: NIS-OBR-DUM-2010/1
• Secondary ID: D6998L00002
• Status: Terminated
• Phase: N/A
• First received: January 12, 2011
• Last updated: December 5, 2012
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Mogi das Cruzes
Brazil	Research Site	Porto Alegre	RS
Brazil	Research Site	Ribeirao Preto
Brazil	Research Site	Rio de Janeiro	RJ
Brazil	Research Site	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the treatment choice by the medical oncologist for each patient.		12 months	No
Secondary	To assess determinants of treatment choice		12 months	No
Secondary	To assess the duration of treatment with chemotherapy or endocrine therapy		12 months	No
Secondary	To evaluate the rate of treatment continuation at 6 months	Assess the profile of adverse events with each treatment modality and assess patient participation and understanding in treatment choice	12 months	No