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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00010153
• Other study ID #: EORTC-10963
• Secondary ID: EORTC-10963BIG-E
• Status: Terminated
• Phase: Phase 3
• First received: February 2, 2001
• Last updated: July 18, 2012
• Start date: November 2000

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: October 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage I or II primary operable breast cancer

• Surgery planned within next 1-4 weeks

• Hormone receptor status:

• Estrogen receptor positive or unknown

• No known estrogen receptor negative tumor

• Unknown progesterone receptor status eligible

PATIENT CHARACTERISTICS:

Age:

• Any age

Sex:

• Female

Menopausal status:

• Premenopausal or postmenopausal

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• No bleeding diathesis not compatible with an IM depot injection

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective non-hormonal contraception during and for 2-3 months after study

• No other prior or concurrent malignancy except adequately treated basal cell carcinoma of the skin or cancer of the uterine cervix

• No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• At least 2 months since prior ICI 182780

Radiotherapy:

• No prior radiotherapy to primary tumor

Surgery:

• See Disease Characteristics

Other:

• No other concurrent preoperative therapy for breast cancer

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• fulvestrant

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United Kingdom	Christie Hospital N.H.S. Trust	Manchester	England

Sponsors (2)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	Breast International Group

Country where clinical trial is conducted

United Kingdom,