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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Postmenopause, Breast Cancer

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Trial Information

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


Inclusion Criteria:



- Signed written informed consent

- Female postmenopausal patient (or patient post-ovarectomy) 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 Exemestan 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 Exemestan for patients who receive treatment with Exemestan
within this observational study

- Acutely life threatening disease

- Treatment with Faslodex 250 mg/month (previously approved dose)

- Prior palliative chemotherapy

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease.

Outcome Time Frame:

Period from inclusion up to 9 months (average time period )

Safety Issue:

No

Principal Investigator

Nicolai Maass, Prof. Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

52074 Aachen, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

NIS-ODE-FAS-2009/1

NCT ID:

NCT01171417

Start Date:

August 2010

Completion Date:

November 2013

Related Keywords:

  • Postmenopause
  • Breast Cancer
  • Fulvestrant
  • Exemestane
  • postmenopausal patients
  • advanced HR+ breast cancer
  • Hormone Receptor positive
  • advanced breast cancer
  • Breast Neoplasms

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