A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Aachen, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Real-life data on patient outcomes by line of treatment (i.e. 1st vs. 2nd vs. 3rd line).

Time frame: Every 3 months

Including overall survival (OS), progression-free survival (PFS),time to progression (TTP), response rate (RR) and clinical benefit rate (CBR)
Real-life pharmacoeconomic data and use of health care resources.

Time frame: Every 3 months

According to lines of treatment and other patient related factors (such as age, co-morbidities etc.), including primary care visits, hospital stays and other resource
Health-related quality of life (HRQoL) in patients undergoing treatment with Faslodex 500 mg or exemestane.

Time frame: Every 3 months

Health-related quality of life will be assessed with a patient-based instrument (eg, EQ5D).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ACT-FASTER:

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jul 28, 2010
Registry last updated: Feb 27, 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.

Published trials that share one or more normalized conditions with this study.

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