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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447328
• Other study ID #: D6998L00004
• Status: Completed
• Phase: Phase 4
• Start date: May 29, 2015
• Est. completion date: September 16, 2020

Study information

• Verified date: September 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 16, 2020
• Est. primary completion date: May 6, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced or
• Metastatic Breast Cancer

Intervention

Drug:
• Fulvestrant
fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Cheongju-si
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Goyang-si
Korea, Republic of	Research Site	Seo-Gu
Korea, Republic of	Research Site	Seongnam-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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