Faslodex Post Marketing Surveillance

Breast Cancer Clinical Trial

Official title:

Faslodex Post Marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860561
• Other study ID #: D6997L00018
• Status: Completed
• Phase: N/A
• First received: March 11, 2009
• Last updated: October 9, 2014
• Start date: January 2009
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This PMS aims to assess the efficacy, the safety and tolerability profile of Faslodex in everyday practice. Secondary objective of this PMS is to identify the frequency of serious adverse events or any unknown adverse events of Faslodex.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Postmenopausal women

• Patients who have failed 2 or more prior hormone therapies (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)

• Patients who were intolerant to prior hormone therapy and have no endocrine therapeutic options (The prior hormone therapies should contain both antiestrogen and non-steroidal Aromatase inhibitor)

Exclusion Criteria:

• The patients who received Faslodex treatment before

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Cheonan
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Iksan
Korea, Republic of	Research Site	Jeonju
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events are confirmed by investigator through asking to patients or patients' voluntary reporting.		5 years	No
Primary	Efficacy of Faslodex is assessed by proper method among CT scan, MRI, Ultrasound, etc. The RECIST criteria for target and non-target lesions will be used to evaluate efficacy.		5 years	No

External Links

•   CSR_Synopsis_D6997L00018