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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01171417
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : February 27, 2014
Information provided by (Responsible Party):

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.

Condition or disease
Postmenopause Breast Cancer

Study Type : Observational
Actual Enrollment : 570 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : August 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Cohort 1
1st-line Faslodex 500 mg
Cohort 2
2nd-line Faslodex 500 mg
Cohort 3
3rd- line Faslodex 500 mg
Cohort 4
patients on exemestane

Primary Outcome Measures :
  1. Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease. [ Time Frame: Period from inclusion up to 9 months (average time period ) ]
  2. Disease management data [ Time Frame: 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 Outcome Measures :
  1. Real-life data on patient outcomes by line of treatment (i.e. 1st vs. 2nd vs. 3rd line). [ Time Frame: Every 3 months ]
    Including overall survival (OS), progression-free survival (PFS),time to progression (TTP), response rate (RR) and clinical benefit rate (CBR)

  2. Real-life pharmacoeconomic data and use of health care resources. [ Time Frame: 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

  3. Health-related quality of life (HRQoL) in patients undergoing treatment with Faslodex 500 mg or exemestane. [ Time Frame: Every 3 months ]
    Health-related quality of life will be assessed with a patient-based instrument (eg, EQ5D).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
660 patients in 140 sites in Germany. 100 specialists and 40 hospitals. Each site should enrol 4-20 patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01171417

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Sponsors and Collaborators
Principal Investigator: Nicolai Maass, Prof. Dr. med. 52074 Aachen, Germany

Responsible Party: AstraZeneca Identifier: NCT01171417     History of Changes
Other Study ID Numbers: NIS-ODE-FAS-2009/1
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014

Keywords provided by AstraZeneca:
postmenopausal patients
advanced HR+ breast cancer
Hormone Receptor positive
advanced breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action