ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer
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ClinicalTrials.gov Identifier: NCT00010153 |
Recruitment Status :
Terminated
(low accrual)
First Posted : January 27, 2003
Last Update Posted : July 19, 2012
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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 |
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 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 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed stage I or II primary operable breast cancer
- Surgery planned within next 1-4 weeks
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010153
United Kingdom | |
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 | The Christie NHS Foundation Trust |
Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
ClinicalTrials.gov Identifier: | NCT00010153 |
Other Study ID Numbers: |
EORTC-10963 EORTC-10963 BIG-EORTC-10963 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | July 19, 2012 |
Last Verified: | July 2012 |
stage I breast cancer stage II breast cancer |
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 |