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Faslodex Specific Clinical Experience Investigation

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.
ClinicalTrials.gov Identifier: NCT01501266
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease
Breast Cancer

Detailed Description:
MC MD

Study Type : Observational
Estimated Enrollment : 660 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Faslodex Specific Clinical Experience Investigation for Long-term Use
Study Start Date : February 2012
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

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

Group/Cohort
Faslodex



Primary Outcome Measures :
  1. Incidence of adverse drug reactions. [ Time Frame: 1 year ]
  2. Incidence of serious adverse events. [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. Incidence of adverse drug reactions with injection site reaction, thromboembolic events and hepatic impairment [ Time Frame: 1 year ]
  2. Progression-free survival [ Time Frame: 6 month ]
  3. Progression-free survival [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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:


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 ClinicalTrials.gov identifier (NCT number): NCT01501266


Locations
Japan
Research Site
Aichi, Japan
Research Site
Akita, Japan
Research Site
Aomori, Japan
Research Site
Chiba, Japan
Research Site
Fukui, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Gifu, Japan
Research Site
Gunma, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyogo, Japan
Research Site
Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Kagawa, Japan
Research Site
Kagoshima, Japan
Research Site
Kanagawa, Japan
Research Site
Kochi, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Miyagi, Japan
Research Site
Miyazaki, Japan
Research Site
Nagano, Japan
Research Site
Nagasaki, Japan
Research Site
Nara, Japan
Research Site
Niigata, Japan
Research Site
Oita, Japan
Research Site
Okayama, Japan
Research Site
Okinawa, Japan
Research Site
Osaka, Japan
Research Site
Saga, Japan
Research Site
Saitama, Japan
Research Site
Shiga, Japan
Research Site
Shizuoka, Japan
Research Site
Tochigi, Japan
Research Site
Tokushima, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
Research Site
Toyama, Japan
Research Site
Wakayama, Japan
Research Site
Yamagata, Japan
Research Site
Yamaguchi, Japan
Research Site
Yamanashi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Shigeru Yoshida AstraZeneca KK

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01501266     History of Changes
Other Study ID Numbers: D6997C00008
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016

Keywords provided by AstraZeneca:
postmenopausal breast cancer
Faslodex
cohort

Additional relevant MeSH terms:
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs