Faslodex Specific Clinical Experience Investigation

Faslodex Specific Clinical Experience Investigation for Long-term Use

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01501266

Enrollment

660

Registered

2011-12-29

Start date

2012-02-29

Completion date

2015-01-31

Last updated

2016-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

postmenopausal breast cancer, Faslodex, cohort

Brief summary

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.

Detailed description

MC MD

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Incidence of adverse drug reactions.	1 year
Incidence of serious adverse events.	1 Year

Secondary

Measure	Time frame
Incidence of adverse drug reactions with injection site reaction, thromboembolic events and hepatic impairment	1 year
Progression-free survival	6 month

Countries

Japan

Outcome results