Collection of Efficacy and Safety Data of Chinese Patients Who Have Received Faslodex 250mg Treatment

Study Overview
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Brief Summary
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This study is a post-authorisation study, committed to Center for Drug Evaluation (CDE) and China Food and Drug Administration (CFDA), in order to provide more effectiveness and safety data about Faslodex in real world clinical practice in China. The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.

Detailed Description
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A Multicenter, non-interventional, prospective study to collect effectiveness and safety data in Chinese patients who have received Faslodex treatment under the condition of actual usage in clinical practice

Official Title
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A Multicenter, Non-interventional, Prospective Study to Collect Efficacy and Safety Data in Chinese Patients Who Have Received Faslodex 250mg Treatment Under the Condition of Actual Usage in Clinical Practice

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer Failure to previous anti-estrogen therapy, already received Faslodex 250mg treatment as determined by treating physician. The prescription of the Faslodex is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Faslodex injection. Provision of subject informed consent. Exclusion Criteria: If participating in any controlled clinical trial, the subject cannot take part in this study. Hypersensitivity to the active substance, or to any of the other excipients. Pregnancy and lactation, or severe hepatic impairment.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with ER+ locally advanced or MBC in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice. | The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice. | Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR was defined as the percentage of patients who had a best objective tumour response of either complete response (CR) or partial response (PR) among the evaluable patients with measurable disease at baseline. The best overall response was the best response recorded from the start of the treatment until disease progression. The RECIST1.1 criteria were used to assess objective tumour response. ORR was summarized and expressed as the percentage together with the corresponding 95% confidence intervals (CI). | Follow-up will be taken every 3 months after commencement of the protocol, through the study completion, an average of 12 months. | 
| Frequency of Adverse Events | Adverse events (AEs) data were coded using Medical dictionary for Regulatory Activities (MedDRA) version 14.0 and summarized by preferred term (PT) and system organ class (SOC). | Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months. | 
| Severity of Adverse Events | SAEs causally related to study drug, AEs leading to discontinuation, AEs leading to death, respectively. Separate listings were provided for AEs causally related to study drug, AEs leading to death, respectively. The severity of all adverse events was analyzed according to CTCAE grading. | Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese post-menopausal women, oestrogen receptor-positive locally advanced, metastatic breast cancer, fulvestrant 250 mg, failure to adjuvant anti-oestrogen therapy