Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01171417
First received: June 23, 2010
Last updated: February 26, 2014
Last verified: February 2014
  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:


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).


Enrollment: 570
Study Start Date: August 2010
Study Completion Date: November 2013
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-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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 26, 2014
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Exemestane
Fulvestrant
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014