We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(The study has been decided to be early terminated for the FAS 500 mg has launched in 2015. The use mothod of 250mg per month in clinical practice is off-label.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425294
First Posted: August 30, 2011
Last Update Posted: December 5, 2017
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.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
This study is a post-authorisation study, committed to Center for Drug Evaluation (CDE) and China Food and Drug Administration (CFDA), in order to provide more effectiveness and safety data about Faslodex in real world clinical practice in China. The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Other
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:
  • To evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with ER+ locally advanced or MBC in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice. [ Time Frame: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months. ]
    The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.


Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Follow-up will be taken every 3 months after commencement of the protocol, through the study completion, an average of 12 months. ]
    ORR was defined as the percentage of patients who had a best objective tumour response of either complete response (CR) or partial response (PR) among the evaluable patients with measurable disease at baseline. The best overall response was the best response recorded from the start of the treatment until disease progression. The RECIST1.1 criteria were used to assess objective tumour response. ORR was summarized and expressed as the percentage together with the corresponding 95% confidence intervals (CI).

  • Frequency of Adverse Events [ Time Frame: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months. ]
    Adverse events (AEs) data were coded using Medical dictionary for Regulatory Activities (MedDRA) version 14.0 and summarized by preferred term (PT) and system organ class (SOC).

  • Severity of Adverse Events [ Time Frame: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months. ]
    SAEs causally related to study drug, AEs leading to discontinuation, AEs leading to death, respectively. Separate listings were provided for AEs causally related to study drug, AEs leading to death, respectively. The severity of all adverse events was analyzed according to CTCAE grading.


Enrollment: 231
Actual Study Start Date: August 1, 2011
Study Completion Date: January 30, 2016
Primary Completion Date: January 30, 2016 (Final data collection date for primary outcome measure)
Detailed Description:
A Multicenter, non-interventional, prospective study to collect effectiveness and safety data in Chinese patients who have received Faslodex treatment under the condition of actual usage in clinical practice
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
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): NCT01425294


  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

Additional Information:
Publications:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01425294     History of Changes
Other Study ID Numbers: NIS-OCN-FAS-2011/1
First Submitted: August 19, 2011
First Posted: August 30, 2011
Last Update Posted: December 5, 2017
Last Verified: December 2017

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

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