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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01171417
First received: June 23, 2010
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Postmenopause
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ) ] [ Designated as safety issue: No ]
  • Disease management data [ Time Frame: Period from inclusion up to 9 months (average time period ) ] [ Designated as safety issue: No ]
    The analysis will be adjusted for the main prognostic factors, such as visceral metastases, age, receptor status etc


Secondary Outcome Measures:
  • Real-life data on patient outcomes by line of treatment (i.e. 1st vs. 2nd vs. 3rd line). [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
    Health-related quality of life will be assessed with a patient-based instrument (eg, EQ5D).


Estimated Enrollment: 570
Study Start Date: August 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171417

  Show 92 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Nicolai Maass, Prof. Dr. med. 52074 Aachen, Germany
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01171417     History of Changes
Other Study ID Numbers: NIS-ODE-FAS-2009/1, NIS-ODE-FAS-2009/1
Study First Received: June 23, 2010
Last Updated: March 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Fulvestrant
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 23, 2013