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

AstraZeneca

Status

Completed

Conditions

Breast Cancer

Postmenopause

Study type

Observational

Funder types

Industry

Identifiers

NCT01171417

NIS-ODE-FAS-2009/1

Details and patient eligibility

About

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.

Enrollment

570 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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