Status:
COMPLETED
A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Postmenopause
Breast Cancer
Eligibility:
FEMALE
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT01171417
Start Date
August 1 2010
End Date
November 1 2013
Last Update
February 27 2014
Active Locations (92)
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1
Research Site
Aachen, Germany
2
Research Site
Ahaus, Germany
3
Research Site
Amberg, Germany
4
Research Site
Aschaffenburg, Germany