Parameters of Acceptability, Compliance and Efficacy of Fulvestrant in Post-menopausal Patients With Advance Breast Cancer (FRAME)

January 4, 2011 updated by: AstraZeneca

Non-interventional Report on Parameters of Acceptability, Efficacy and Compliance of Fulvestrant in Post-menopausal Patients With Advanced Breast Cancer HR Positive Who Progresses to One Prior Endocrine Therapy With Antiestrogens

The objectives of this study is to obtain information of Faslodex use in the treatment of breast cancer in the clinical practice in Argentina.

Study Overview

Status

Completed

Conditions

Detailed Description

In Argentina, Faslodex is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. This study will provide information regarding the acceptability and compliance of Argentina patients to Faslodex and will provide information regarding the efficacy of this treatment in local population.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cordoba, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
      • Tucuman, Argentina
        • Research Site
    • Buenos Aires
      • Bahia Blanca, Buenos Aires, Argentina
        • Research Site
      • Campana, Buenos Aires, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Buenos Aires, Argentina
        • Research Site
      • La Plata, Buenos Aires, Argentina
        • Research Site
      • Mar del Plata, Buenos Aires, Argentina
        • Research Site
      • Moron, Buenos Aires, Argentina
        • Research Site
      • Pergamino, Buenos Aires, Argentina
        • Research Site
      • San Martin, Buenos Aires, Argentina
        • Research Site
      • Tandil, Buenos Aires, Argentina
        • Research Site
      • Vicente Lopez, Buenos Aires, Argentina
        • Research Site
    • La Pampa
      • Santa Rosa, La Pampa, Argentina
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
    • Tierra del Fuego
      • Rio Grande, Tierra del Fuego, Argentina
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Post-menopausal women with advanced breast cancer hormone receptor-positive who have progressed to a one prior hormone therapy.

Description

Inclusion Criteria:

  • Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-estrogen therapy or disease progression during anti-estrogen treatment, currently receiving Faslodex
  • Signature of the informed consent

Exclusion Criteria:

  • Any contraindication to Faslodex administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To collect real life data of acceptability and compliance on the use of Faslodex in the Argentine population.
Time Frame: monthly
monthly
To collect real life data of efficacy on the use of Faslodex in the Argentine population.
Time Frame: monthly
monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 8, 2009

First Submitted That Met QC Criteria

April 8, 2009

First Posted (Estimate)

April 9, 2009

Study Record Updates

Last Update Posted (Estimate)

January 5, 2011

Last Update Submitted That Met QC Criteria

January 4, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • NIS-OAR-FAS-2008/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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