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

Tracking Information

First Received Date ^ICMJE

February 2, 2001

Last Updated Date

February 6, 2009

Start Date ^ICMJE

November 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00010153 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: fulvestrant
Procedure: conventional surgery

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00010153

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068451, EORTC-10963, BIG-EORTC-10963

Study Sponsor ^ICMJE

European Organization for Research and Treatment of Cancer

Collaborators ^ICMJE

Breast International Group

Investigators ^ICMJE

Study Chair:	Cornelis J.H. van de Velde, MD, PhD, FRCS, FRCPS	Leiden University Medical Center
Study Chair:	Anthony Howell, MD	Christie Hospital NHS Foundation Trust

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP