NCT00012025

ICI 182780 in Treating Women With Metastatic Breast Cancer

Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells. PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy.

Detailed description

OBJECTIVES: * Determine the complete and partial objective response rate and duration of response in women with metastatic breast cancer who have failed aromatase inhibitor therapy treated with fulvestrant. * Determine the time to disease progression and overall survival of women treated with this drug. * Determine the toxicity of this drug in these women. OUTLINE: Patients receive fulvestrant intramuscularly on day 1. Courses repeat approximately every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until disease progression. After disease progression, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	fulvestrant

Timeline

• Start date: 2001-05-01
• Primary completion: 2006-03-01
• Completion: 2008-08-01
• First posted: 2003-01-27
• Last updated: 2016-07-06

Locations

25 sites across 2 countries: United States, Canada