Retrospective Study Assessment Treatment Response Faslodex®( 500 mg) (EFFICACY)
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Purpose
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 |
|---|
|
Malignant Neoplasm of Breast Stage IV |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Assessment of Treatment Response With Faslodex® (500 mg) in Standard Clinical Practice Through a Retrospective Study |
- Progression Free Survival [ Time Frame: 22 months ] [ Designated as safety issue: No ]Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival
- Clinical Benefit Rate [ Time Frame: 22 months ] [ Designated as safety issue: No ]Response to treatment with fulvestrant in terms of Clinical Benefit Rate
- Overall Survival [ Time Frame: 22 months ] [ Designated as safety issue: No ]Response to treatment with fulvestrant in terms of Overall Survival
- Duration of Clinical Benefit [ Time Frame: 22 months ] [ Designated as safety issue: No ]Response to treatment with fulvestrant in terms of Duration of the Clinical Benefit
- Number of Participants with Adverse Events [ Time Frame: 22 months ] [ Designated as safety issue: Yes ]
- Response to treatment with fulvestrant in terms of PFS, CBR, ORR, OS and DCB in a subgroup of patients with visceral metastases and without visceral metastases [ Time Frame: 22 months ] [ Designated as safety issue: No ]Response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS, CBR, OS and DCB in a subgroup of patients with visceral metastases and without visceral metastases
- Response to treatment with fulvestrant in terms of PFS, CBR, ORR, OS and DCB 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 ] [ Designated as safety issue: No ]To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS, CBR, ORR, OS and DCB 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, and compare both groups
- Response to treatment with fulvestrant in terms of PFS, CBR, ORR, OS and DCB in subgroups of patients with her-2 overexpression and those who do not over-express her-2 [ Time Frame: 22 months ] [ Designated as safety issue: No ]To assess the response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS, CBR, OS and DCB 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
- Response to treatment with fulvestrant in terms of PFS, CBR, ORR, OS and DCB in a subgroup of patients with elevated ki-67 and with low ki-67 [ Time Frame: 22 months ] [ Designated as safety issue: No ]To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS, CBR, OS and DCB 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
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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| Contact: Isabel Blancas, MD | +34958-023609 | blancaslb@hotmail.com |
| Spain | |
| Hospital Torrecardenas Almería | Not yet recruiting |
| Almería, Spain | |
| Contact: Antonia Martínez, MD | |
| Sub-Investigator: Antonia Martínez, MD | |
| Sub-Investigator: Fernando Rosillo, MD | |
| Hospital San Cecilio | Not yet recruiting |
| Granada, Spain | |
| Contact: Isabel Blancas, MD +34958-023609 blancaslb@hotmail.com | |
| Principal Investigator: Maite Delgado, MD | |
| Principal Investigator: Marta Legerén, MD | |
| Principal Investigator: Isabel Blancas, MD | |
| Hospital Universitario Virgen de las Nieves | Not yet recruiting |
| Granada, Spain | |
| Contact: Encarna González, MD | |
| Sub-Investigator: Encarna González, MD | |
| Sub-Investigator: Verónica Conde, MD | |
| Complejo Hospitalario de Jaén | Not yet recruiting |
| Jaén, Spain | |
| Contact: Ana Jaen, MD | |
| Sub-Investigator: Ana Jaen, MD | |
| Sub-Investigator: Pedro Sánchez, MD | |
| Hospital SAS Jeréz de la Frontera | Not yet recruiting |
| Jeréz de la Frontera, Spain | |
| Contact: María del Mar Gordon, MD | |
| Sub-Investigator: María del Mar Gordon, MD | |
| Hospital Costa del Sol | Not yet recruiting |
| Marbella, Spain | |
| Contact: Elisabet Pérez, MD | |
| Sub-Investigator: Elisabet Pérez, MD | |
| Hospital Carlos Hayas | |
| Málaga, Spain | |
| Principal Investigator: | Isabel Blancas, MD |
More Information
No publications provided
| Responsible Party: | Isabel Blancas, Medical Doctor, Hospital Clinico Universitario San Cecilio |
| ClinicalTrials.gov Identifier: | NCT01509625 History of Changes |
| Other Study ID Numbers: | MIB-FUL-2011-01 |
| Study First Received: | December 29, 2011 |
| Last Updated: | January 10, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Hospital Clinico Universitario San Cecilio:
|
Fulvestrant Faslodex |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Fulvestrant Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 23, 2013