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

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT01425294
• Lead Sponsor: AstraZeneca

Brief Summary

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

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

Study Timeline

• Study Start: 2011-08-01
• Study First Submitted: 2011-08-19
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-30
• Primary Completion: 2016-01-30
• Study Completion: 2016-01-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 231

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.	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.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Follow-up will be taken every 3 months after commencement of the protocol, through the study completion, an average of 12 months.	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).
Severity of Adverse Events	Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.	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.
Frequency of Adverse Events	Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.	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).

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhoushan, Zhejiang, China