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Spots Global Cancer Trial Database for Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)

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Trial Identification

Brief Title: Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)

Official Title: Assessment of Treatment Response With Faslodex® (500 mg) in Standard Clinical Practice Through a Retrospective Study

Study ID: NCT01509625

Interventions

Fulvestrant

Study Description

Brief Summary: This retrospective observational study is designed to assess the response to treatment with fulvestrant at a dose of 500 mg/month with a loading dose of 500 mg (LD-500), in terms of progression free survival (PFS), overall survival (OS), and clinical benefit rate (CBR), in post-menopausal women with Advanced Breast Cancer and estrogen receptor positive, who were treated with this medicinal product and at said dose after having progressed with a previous anti-estrogen therapy. During this study, a retrospective data collection will be carried out using the information contained in the Clinical History of said patients, provided that the treatment with fulvestrant at a dose of 500 mg and LD-500.

Detailed Description: Based on the results of the CONFIRM Study, a centralised change in the dosage of Faslodex® to 500 mg/month, with an additional pre-loading dose of 500 mg fourteen days after treatment smart was authorised in Europe; the dose is indicated for the treatment of post-menopausal women with ABC, hormone receptor positive and whose disease had progressed after anti-estrogen therapy. Several sites worldwide participated in this study, but given the importance of the results obtained and their impact, we believe it is important to have local data available in Spain that would enable us to determine how this new 500 mg dose of Faslodex® behaves in the treatment and to assess treatment response within standard clinical practice and the current indications of this drug. Therefore, we designed this retrospective, observational study in which we will measure response in term of PFS using data collected from the Clinical History. Likewise, other variables will be studied: OS, CBR, duration of clinical benefit, tolerability and safety. Patient subgroups, like those who over-express her-2, according to levels of ki-67 and the presence or not of visceral metastases will also be studied. This retrospective observational study is designed to assess the response to treatment with fulvestrant at a dose of 500 mg/month with a loading dose of 500 mg (LD-500), in terms of progression free survival (PFS), overall survival (OS), clinical benefit rate (CBR), and duration of clinical benefit (DCB, in post-menopausal women with Advanced Breast Cancer and estrogen receptor positive, who were treated with this medicinal product and at said dose after having progressed with a previous anti-estrogen therapy. During this study, a retrospective data collection will be carried out using the information contained in the Clinical History of said patients, provided that the treatment with fulvestrant at a dose of 500 mg and LD-500, had occurred at some point between 1 January 2010 and 31 October 2011 (hereinafter, the study period). Thus, we will obtain the PFS, OS and CBR data, as well as information on safety and tolerability.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Hospital Torrecardenas Almería, Almería, , Spain

Hospital San Cecilio, Granada, , Spain

Hospital Universitario Virgen de las Nieves, Granada, , Spain

Complejo Hospitalario de Jaén, Jaén, , Spain

Hospital SAS Jeréz de la Frontera, Jeréz de la Frontera, , Spain

Hospital Costa del Sol, Marbella, , Spain

Hospital Carlos Hayas, Málaga, , Spain

Contact Details

Name: Isabel Blancas, MD

Affiliation:

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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