Malignant Neoplasm of Breast Stage IV Clinical Trial
— EFFICACYOfficial title:
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | March 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| 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 Carlos Hayas | Málaga | |
| Spain | Hospital Costa del Sol | Marbella |
| Lead Sponsor | Collaborator |
|---|---|
| Isabel Blancas |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival | Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival | 22 months | No |
| Secondary | Clinical Benefit Rate | Response to treatment with fulvestrant in terms of Clinical Benefit Rate | 22 months | No |
| Secondary | Overall Survival | Response to treatment with fulvestrant in terms of Overall Survival | 22 months | No |
| Secondary | Duration of Clinical Benefit | Response to treatment with fulvestrant in terms of Duration of the Clinical Benefit | 22 months | No |
| Secondary | Number of Participants with Adverse Events | 22 months | Yes | |
| Secondary | 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 | 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 | 22 months | No |
| Secondary | 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 | 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 | 22 months | No |
| Secondary | 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 | 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 | 22 months | No |
| Secondary | 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 | 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 | 22 months | No |