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Completed

NCT Number: NCT01501266

Faslodex Specific Clinical Experience Investigation

The purpose of this study is to confirm the safety profile such as the frequency of serious adverse events or any unexpected adverse events and overall efficacy of Faslodex for long term treatment in daily clinical practice.

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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, Aichi, Japan

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About this study

MC MD

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients treated with Faslodex for the first time due to postmenopausal breast cancer

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Incidence of adverse drug reactions.

    Time frame: 1 year

  2. Incidence of serious adverse events.

    Time frame: 1 Year

Secondary outcomes

  1. Incidence of adverse drug reactions with injection site reaction, thromboembolic events and hepatic impairment

    Time frame: 1 year

  2. Progression-free survival

    Time frame: 6 month

  3. Progression-free survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Faslodex Specific Clinical Experience Investigation for Long-term Use

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 29, 2011
Registry last updated
May 10, 2016

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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