Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)

NCT ID: NCT01509625

Last Updated: 2016-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 272 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-03-31

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.

Conditions

Malignant Neoplasm of Breast Stage IV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Fulvestrant

It is an observacional retrospective study to asses the results of the administration of fulvestrant in the routine clinical practice.

Intervention Type: DRUG

Other Intervention Names

Faslodex (registered)

Eligibility Criteria

Inclusion Criteria

• Signed Informed Consent from patients when possible.
• In the event of patients who are deceased at the time of inclusion, no signed informed consent will be available; thus, the investigator assumes the responsibility of data protection and confidentiality and of safeguarding the processing of the data.
• Post-menopausal women.
• Diagnosed with locally advanced or Metastatic Breast Cancer with histological/cytological confirmation.
• Documented estrogen receptor positive status for the primary tumour.
• Patient who, after progression with a previous anti-estrogen treatment, received treatment at some time with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose during the study period.

Exclusion Criteria

• Having received treatment with unapproved or experimental drugs during the study period.
• Presenting another concomitant cancer other than stage I cervical cancer or cutaneous tumours without lymph node or distant involvement.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Isabel Blancas

OTHER

Sponsor Role: lead

Responsible Party

Isabel Blancas

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Isabel Blancas, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital San Cecilio

Granada, Granada, Spain

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Hospital Torrecardenas Almería

Almería, , 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

Countries

Spain

Other Identifiers

MIB-FUL-2011-01

Identifier Type: -

Identifier Source: org_study_id