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

Sponsor:	European Organization for Research and Treatment of Cancer - EORTC
Collaborator:	Breast International Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00010153

Purpose

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	Intervention	Phase
Breast Cancer	Drug: fulvestrant Procedure: conventional surgery	Phase III

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ici 182780

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 2000

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.

Eligibility

Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010153

Locations

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

Sponsors and Collaborators

European Organization 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	Christie Hospital NHS Foundation Trust

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00010153 History of Changes
Other Study ID Numbers:	CDR0000068451, EORTC-10963, BIG-EORTC-10963
Study First Received:	February 2, 2001
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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
Therapeutic Uses

Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on February 12, 2012