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

NCT ID: NCT02447328

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-29
• Study Completion Date: 2020-09-16

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.

Conditions

Locally Advanced or; Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single Arm

Faslodex treated in the study

Group Type: EXPERIMENTAL

Fulvestrant

Intervention Type: DRUG

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

Interventions

Fulvestrant

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Cheongju-si, , South Korea

Research Site

Daegu, , South Korea

Research Site

Goyang-si, , South Korea

Research Site

Seogu, , South Korea

Research Site

Seongnam-si, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Countries

South Korea

Other Identifiers

D6998L00004

Identifier Type: -

Identifier Source: org_study_id