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Faslodex Specific Clinical Experience Investigation

This study is currently recruiting participants.
Verified May 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01501266
First received: December 27, 2011
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to confirm the safety profile such as the frequency of serious adverse events or any unexpected adverse events and overall efficacy of Faslodex for long term treatment in daily clinical practice.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Faslodex Specific Clinical Experience Investigation for Long-term Use

Resource links provided by NLM:

Drug Information available for: Fulvestrant
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence of adverse drug reactions. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of adverse drug reactions with injection site reaction, thromboembolic events and hepatic impairment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Detailed Description:

MC MD

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated with Faslodex for the first time due to postmenopausal breast cancer

Criteria

Inclusion Criteria:

  • Patients treated with Faslodex for the first time due to postmenopausal breast cancer

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501266

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

  Show 75 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Shigeru Yoshida AstraZeneca KK
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01501266     History of Changes
Other Study ID Numbers: D6997C00008
Study First Received: December 27, 2011
Last Updated: May 17, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
postmenopausal breast cancer
Faslodex
cohort

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
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 22, 2013