An Epidemiological Prospective Cohort Study to Describe Treatment Patterns of Fulvestrant And ExemeSTane in Postmenopausal Patients With Advanced HR+ Breast Cancer Under Real-life Conditions in GERmany

AstraZeneca1 site in 1 country570 target enrollmentAugust 2010

ConditionsPostmenopause Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postmenopause
Sponsor: AstraZeneca
Enrollment: 570
Locations: 1
Primary Endpoint: Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line). For all patients, to collect and explore real-life data on the epidemiology and management of Pseudomyxoma Peritonea (PMP) patients with HR+ advanced breast cancer (ABC) treated with Faslodex 500 mg or exemestane.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

November 2013

Last Updated

12 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed written informed consent
•Female postmenopausal patient (or patient post-ovariectomy) and age ≥18 years Postmenopause ist defined as
•Age ≥ 60 years and natural menopause with menses \> 1year ago or
•FSH and E2 levels in the postmenopausal range or
•Patients who had bilateral ovariectomy (NCCN V.I. 2009)
•Histologically confirmed ER+ locally advanced or metastatic breast cancer
•Not eligible for curative therapy
•Prior treatment with tamoxifen
•Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI
•Patient is able to read and understand German

Exclusion Criteria

•Known hypersensitivity to Faslodex or Exemestane or any compounds of the drugs
•Prior treatment with Faslodex 500 mg or Faslodex 250 mg\*
•for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.
•Prior treatment with Exemestane for patients who receive treatment with Exemestane within this observational study
•Acutely life threatening disease
•Treatment with Faslodex 250 mg/month (previously approved dose)
•Prior palliative chemotherapy

Outcomes

Primary Outcomes

Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease.

Time Frame: Period from inclusion up to 9 months (average time period )

Disease management data

Time Frame: Period from inclusion up to 9 months (average time period )

The analysis will be adjusted for the main prognostic factors, such as visceral metastases, age, receptor status etc

Secondary Outcomes

Health-related quality of life (HRQoL) in patients undergoing treatment with Faslodex 500 mg or exemestane.(Every 3 months)
Real-life data on patient outcomes by line of treatment (i.e. 1st vs. 2nd vs. 3rd line).(Every 3 months)
Real-life pharmacoeconomic data and use of health care resources.(Every 3 months)