Retrospective Study Assessment Treatment Response Faslodex®( 500 mg) (EFFICACY)

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm of Breast Stage IV
• Intervention / Treatment: Drug: Fulvestrant

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.

• Study Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• Spain
  • Almería, Spain
    • Hospital Torrecardenas Almería
  • Granada, Spain
    • Hospital San Cecilio
  • Granada, Spain
    • Hospital Universitario Virgen de las Nieves
  • Jaén, Spain
    • Complejo Hospitalario de Jaen
  • Jeréz de la Frontera, Spain
    • Hospital SAS Jeréz de la Frontera
  • Marbella, Spain
    • Hospital Costa del Sol
  • Málaga, Spain
    • Hospital Carlos Hayas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (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 (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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	22 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Benefit Rate	Response to treatment with fulvestrant in terms of Clinical Benefit Rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).	22 months
Overall Survival	Response to treatment with fulvestrant in terms of Overall Survival	22 months
Duration of Clinical Benefit	Response to treatment with fulvestrant in terms of Duration of the Clinical Benefit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).	22 months
Number of Participants With Adverse Events		22 months
Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases	Response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in a subgroup of patients with visceral metastases and without visceral metastases. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).	22 months
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	To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose 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	22 months
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	To assess the response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in subgroups of patients with her-2 overexpression (+++ by immunohistochemistry or FISH positive) and those who do not over-express her-2 and to compare both groups. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).	22 months
Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67	To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients with elevated ki-67 (greater than or equal to 20%) and with low ki-67 and to compare both groups	22 months

Collaborators and Investigators

• Sponsor: Isabel Blancas
• Investigators: Principal Investigator: Isabel Blancas, MD

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: December 29, 2011
• First Submitted That Met QC Criteria: January 10, 2012
• First Posted (ESTIMATE): January 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 1, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Fulvestrant; Faslodex
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant
• Other Study ID Numbers: MIB-FUL-2011-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED