Clinical trial NCT01509625: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm of Breast Stage IV
Keywords: Fulvestrant
Faslodex
Lead sponsor: Hospital Clinico Universitario San Cecilio
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 272
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-menopausal women with Advanced Breast Cancer (ABC) and estrogen receptor positive (ER+) who were treated with this medicinal product and at said dose after having progressed with a previous anti-estrogen therapy

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 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 22 months
Secondary outcomes:
measure: Clinical Benefit Rate
timeFrame: 22 months
measure: Overall Survival
timeFrame: 22 months
measure: Duration of Clinical Benefit
timeFrame: 22 months
measure: Number of Participants With Adverse Events
timeFrame: 22 months
measure: Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases
timeFrame: 22 months
measure: Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients After a First-line Hormonal Therapy Prior and in Subgroup of Patients After Two or More Prior Lines of Hormonal Therapy
timeFrame: 22 months
measure: Response to Treatment With Fulvestrant in Terms of PFS in Subgroups of Patients With Her-2 Overexpression and Those Who do Not Over-express Her-2
timeFrame: 22 months
measure: Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67
timeFrame: 22 months
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Hospital Torrecardenas Almería
city: Granada
country: Spain
facility: Hospital San Cecilio
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Jeréz de la Frontera
country: Spain
facility: Hospital SAS Jeréz de la Frontera
city: Marbella
country: Spain
facility: Hospital Costa del Sol
city: Málaga
country: Spain
facility: Hospital Carlos Hayas
Study officials:
name: Isabel Blancas, MD
role: PRINCIPAL_INVESTIGATOR
References: