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

Completed

• Conditions: Postmenopause; Breast Cancer

• Registration Number: NCT01171417
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-23
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Study Start: 2010-08
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 570

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease.	Period from inclusion up to 9 months (average time period )
Disease management data	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 Outcome Measures

Name	Time	Method
Health-related quality of life (HRQoL) in patients undergoing treatment with Faslodex 500 mg or exemestane.	Every 3 months	Health-related quality of life will be assessed with a patient-based instrument (eg, EQ5D).
Real-life data on patient outcomes by line of treatment (i.e. 1st vs. 2nd vs. 3rd line).	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.	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

Trial Locations

Locations (1)

Research Site; 🇩🇪 Zittau, Germany