Clinical trial · Observational
A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Postmenopause | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Cohort 1
- description
- 1st-line Faslodex 500 mg
- label
- Cohort 2
- description
- 2nd-line Faslodex 500 mg
- label
- Cohort 3
- description
- 3rd- line Faslodex 500 mg
- label
- Cohort 4
- description
- patients on exemestane
Primary outcomes (2)
- measure
- Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease.
- timeFrame
- Period from inclusion up to 9 months (average time period )
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available