NCT00010153

ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer

A Double-Blind Phase III Clinical Trial to Compare the Effects of a Pre-Operatively Administered Single Dose of "Faslodex" (Long-Acting ICI 182.780) With Placebo on Tumor Recurrence in Pre- and Postmenopausal Women Treated for Operable First Primary Breast Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases. PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.

Detailed description

OBJECTIVES: * Determine the inhibitory effect of ICI 182780 on the development of metastasis, as measured by disease-free survival and overall survival, in women with operable stage I or II primary breast cancer. * Determine toxicity of this regimen in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and menopausal status (premenopausal vs postmenopausal). Patients are randomized to receive either ICI 182780 IM or placebo IM over 2 minutes on day 1. Patients undergo surgery between days 8 and 29. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 3,656 patients (1,828 per arm) will be accrued for this study within 2 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	fulvestrant
PROCEDURE	conventional surgery

Timeline

• Start date: 2000-11-01
• Primary completion: 2001-10-01
• First posted: 2003-01-27
• Last updated: 2012-07-19

Locations

1 site across 1 country: United Kingdom