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OpenTrials
Completed

NCT Number: NCT00860561

Faslodex Post Marketing Surveillance

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Cheonan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Adverse events are confirmed by investigator through asking to patients or patients' voluntary reporting.

    Time frame: 5 years

  2. 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.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2009
Registry last updated
Oct 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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