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Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer Breast International Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00010153 |
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 |
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Breast Cancer |
Drug: fulvestrant Procedure: conventional surgery |
Phase III |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage I or II primary operable breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United Kingdom, England | |
Christie Hospital N.H.S. Trust | |
Manchester, England, United Kingdom, M20 4BX |
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 |
Study ID Numbers: | CDR0000068451, EORTC-10963, BIG-EORTC-10963 |
Study First Received: | February 2, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00010153 History of Changes |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer |
Estrogen Receptor Modulators Estrogen Antagonists Estrogens Antineoplastic Agents, Hormonal Skin Diseases Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Fulvestrant Breast Neoplasms Hormones Breast Diseases Recurrence |
Estrogen Antagonists Antineoplastic Agents, Hormonal Skin Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Fulvestrant Hormones, Hormone Substitutes, and Hormone Antagonists |
Breast Neoplasms Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases |