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

• Status: Completed
• Trial end date: 2020-09-16
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Estradiol; Fulvestrant

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