MedDataX Logo

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

NCT ID: NCT01277926

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Breast Cancer Hormone Receptor Positive, Advanced Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paulo André Palhares Miranda, Doctor

Role: STUDY_DIRECTOR

MC Brazil

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Research Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Research Site

São Paulo, São Paulo, Brazil

Site Status

Research Site

Belo Horizonte, , Brazil

Site Status

Research Site

Mogi das Cruzes, , Brazil

Site Status

Research Site

Ribeirão Preto, , Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D6998L00002

Identifier Type: OTHER

Identifier Source: secondary_id

NIS-OBR-DUM-2010/1

Identifier Type: -

Identifier Source: org_study_id