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

• ClinicalTrials.gov Identifier: NCT01509625
• Recruitment Status: Completed
• First Posted: January 13, 2012
• Results First Posted: June 1, 2016
• Last Update Posted: June 1, 2016
• Sponsor: Isabel Blancas
• Information provided by (Responsible Party): Isabel Blancas, Hospital Clinico Universitario San Cecilio

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.

Condition or disease	Intervention/treatment
Malignant Neoplasm of Breast Stage IV	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 Design

• Study Type: Observational
• Actual Enrollment: 272 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Assessment of Treatment Response With Faslodex® (500 mg) in Standard Clinical Practice Through a Retrospective Study
• Study Start Date: January 2012
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: March 2014

Groups and Cohorts

Intervention Details:

• Drug: Fulvestrant
  It is an observacional retrospective study to asses the results of the administration of fulvestrant in the routine clinical practice.
  Other Name: Faslodex (registered)

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival [ Time Frame: 22 months ]

   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.

Secondary Outcome Measures :

1. Clinical Benefit Rate [ Time Frame: 22 months ]
   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).
2. Overall Survival [ Time Frame: 22 months ]
   Response to treatment with fulvestrant in terms of Overall Survival
3. Duration of Clinical Benefit [ Time Frame: 22 months ]

   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).

4. Number of Participants With Adverse Events [ Time Frame: 22 months ]
5. Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases [ Time Frame: 22 months ]

   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).

6. 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 [ Time Frame: 22 months ]
   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
7. 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 [ Time Frame: 22 months ]

   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).

8. Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67 [ Time Frame: 22 months ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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

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.

Contacts and Locations

Locations

Spain

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

Sponsors and Collaborators

Isabel Blancas

Investigators

• Principal Investigator: Isabel Blancas, MD

More Information

• Responsible Party: Isabel Blancas, Medical Doctor, Hospital Clinico Universitario San Cecilio
• ClinicalTrials.gov Identifier: NCT01509625
• Other Study ID Numbers: MIB-FUL-2011-01
• First Posted: January 13, 2012
• Results First Posted: June 1, 2016
• Last Update Posted: June 1, 2016
• Last Verified: June 2014

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Isabel Blancas, Hospital Clinico Universitario San Cecilio:

Fulvestrant; Faslodex

Additional relevant MeSH terms:

Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Fulvestrant; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Estrogen Receptor Antagonists; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs