Collection of Efficacy and Safety Data of Chinese Patients Who Have Received Faslodex 250mg Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01425294
First received: August 19, 2011
Last updated: April 1, 2014
Last verified: March 2014
  Purpose

This study is a post-authorisation pharmacoepidemiology study, committed to Center for Drug Evaluation (CDE) and State Food and Drug Administration (SFDA), in order to provide more efficacy and safety data about Faslodex 250mg in real life clinical practice in China. The objective of the post marketing study is to explore the efficacy and tolerability of Fulvestrant (FASLODEX™)250 mg in postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-estrogen therapy or disease progression on therapy with an anti-estrogen.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter, Non-interventional, Prospective Study to Collect Efficacy and Safety Data in Chinese Patients Who Have Received Faslodex 250mg Treatment Under the Condition of Actual Usage in Clinical Practice

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression Free Survival (PFS) is defined as from the start of the initial Faslodex 250mg therapy to the first recorded occurrence of objective disease progression or death from any cause. [ Time Frame: Up to 30 months after the first dose of Fulvestrant according to the NISP ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Up to 30 months after the first dose of Fulvestrant according to the NISP ] [ Designated as safety issue: No ]
  • Frequency of Adverse Events [ Time Frame: Up to 30 months after the first dose of Fulvestrant according to the NISP ] [ Designated as safety issue: Yes ]
  • Severity of Adverse Events [ Time Frame: Up to 30 months after the first dose of Fulvestrant according to the NISP ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 245
Study Start Date: August 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Detailed Description:

A Multicenter, non-interventional, prospective study to collect efficacy and safety data in Chinese patients who have received Faslodex 250mg treatment under the condition of actual usage in clinical practice

  Eligibility

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

Medical units

Criteria

Inclusion Criteria:

  • Chinese postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer Failure to previous anti-estrogen therapy, already received Faslodex 250mg treatment as determined by treating physician.
  • The prescription of the Faslodex is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Faslodex injection.
  • Provision of subject informed consent.

Exclusion Criteria:

  • If participating in any controlled clinical trial, the subject cannot take part in this study.
  • Hypersensitivity to the active substance, or to any of the other excipients.
  • Pregnancy and lactation, or severe hepatic impairment.
  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: NCT01425294

Contacts
Contact: Binghe Xu, MD 86-10-87788495 bhxu@hotmail.com

  Show 23 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Binghe Xu, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

Publications:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01425294     History of Changes
Other Study ID Numbers: NIS-OCN-FAS-2011/1
Study First Received: August 19, 2011
Last Updated: April 1, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Chinese post-menopausal women
oestrogen receptor-positive locally advanced
metastatic breast cancer
fulvestrant 250mg
failure to adjuvant anti-oestrogen therapy

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

ClinicalTrials.gov processed this record on August 25, 2014