N/A
Completed N=272
Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)
Malignant Neoplasm of Breast Stage IV
Source: ClinicalTrials.gov NCT01509625 ↗
Enrolled (actual)
272
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Progression Free Survival — 10.6 month
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
10.6 | — |
| SECONDARY Clinical Benefit Rate |
56.5 | — |
| SECONDARY Overall Survival |
43.2 | — |
| SECONDARY Duration of Clinical Benefit |
18.4 | — |
| SECONDARY Number of Participants With Adverse Events |
35.4; 9.9; 7.2; 6.8; 6.1; 0.8 | — |
| SECONDARY Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases |
10.6; 10 | — |
| SECONDARY 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 |
11.2; 9.2 | — |
| SECONDARY 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 |
10.2; 10.3 | — |
| SECONDARY Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67 |
9.6; 10.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01509625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.