Faslodex Specific Clinical Experience Investigation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01501266
First received: December 27, 2011
Last updated: July 8, 2014
Last verified: July 2014
  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:


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: July 2014
Estimated Primary Completion Date: July 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
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: 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
  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: July 8, 2014
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 July 24, 2014