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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: fulvestrant; Procedure: conventional surgery	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Primary Purpose:	Treatment
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
Study Start Date :	November 2000
Actual Primary Completion Date :	October 2001

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX

Sponsors and Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Breast International Group

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:	NCT00010153 History of Changes
Other Study ID Numbers:	EORTC-10963; BIG-EORTC-10963
First Posted:	January 27, 2003
Last Update Posted:	July 19, 2012
Last Verified:	July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:

stage I breast cancer; stage II breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Fulvestrant; Antineoplastic Agents, Hormonal	Antineoplastic Agents; Estrogen Receptor Antagonists; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs