Breast Cancer, Postmenopause
Conditions
Keywords
Fulvestrant, Exemestane, postmenopausal patients, advanced HR+ breast cancer, Hormone Receptor positive, advanced breast cancer
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
Countries
Germany
Outcome results
None listed