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

Phase 4

Completed

• Conditions: Metastatic Breast Cancer; Locally Advanced or
• Interventions: Drug: Fulvestrant

• Registration Number: NCT02447328
• Lead Sponsor: AstraZeneca

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-18
• Study Start: 2015-05-29
• Primary Completion: 2016-05-06
• Results First Submitted: 2017-04-19
• Results First Submitted QC: 2018-03-21
• Results First Posted: 2018-03-22
• Study Completion: 2020-09-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Fulvestrant	Faslodex treated in the study

Primary Outcome Measures

Name	Time	Method
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)	Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.	Percentage of patients with AEs.

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of