Overview

This trial is active, not recruiting.

Conditions locally advanced or, metastatic breast cancer
Treatment fulvestrant
Phase phase 4
Sponsor AstraZeneca
Start date May 2015
End date May 2016
Trial size 85 participants
Trial identifier NCT02447328, D6998L00004

Summary

This single-arm study aims to assess the safety and tolerability profile of Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events after Fulvestrant (Faslodex®) for about 6 months

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Faslodex treated in the study
fulvestrant
fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.

Primary Outcomes

Measure
Adverse Event
time frame: 6 months

Secondary Outcomes

Measure
Safety as measured by incidence
time frame: 6 months
Efficacy as measured by treatment duration median value
time frame: 6 months
Efficacy as measured by RECIST
time frame: 6 months
Quality of Life as measured by EQ-5D questionnaire
time frame: 6 months

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Post menopausal status women - Outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy. - Estrogen receptor positive - Radiographic progression of disease after the prior therapy - Patients who agree to participate in this study and sign the informed consent Exclusion Criteria: - Patients who are treated with fulvestrant - Patients who are being treated with the other antitumor agents - Pregnancy or lactating women - History of hypersensitivity to any of included ingredients (eg. Castor oil) - Patients who are considered not fit for the study by investigators - Patients who have severe dysfunction of liver or kidney

Additional Information

Official title A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Description This study is a Phase 4, single-arm, safety and tolerability study of fulvestrant (Faslodex®) as 2nd line therapy in postmenopausal women with locally advanced or metastatic breast cancer. All of enrolled patients in this study will be injected fulvestrant (Faslodex®). This study will be performed for about 3 years and approximately 100 patients(actual target will be 80 treated patients) will be enrolled in about 10 investigational sites. After obtaining the written informed consent from the patients, the information of demographic and medical history will be collected and laboratory tests will be performed. Patients who meet the inclusion/exclusion criteria will be injected the fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection. The information of adverse events will be collected after the 1st dose of IP injection. In case that the evaluation of tumor response might be performed in regular clinical practice, those data will also be collected as well. The quality of life will also be measured.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.