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Sponsored by: |
Institute of Cancer Research, United Kingdom |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00253422 |
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not yet known whether giving fulvestrant together with anastrozole is more effective than giving fulvestrant together with a placebo or exemestane alone in treating breast cancer.
PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how well they work compared to fulvestrant and a placebo or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: anastrozole Drug: exemestane Drug: fulvestrant |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Partially-Blind Phase III Randomized Trial of Fulvestrant (Faslodex™) With or Without Concomitant Anastrozole (Arimidex™) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors |
Estimated Enrollment: | 750 |
Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, partially double-blind and placebo-controlled, multicenter study. Patients are stratified according to the setting in which prior nonsteroidal aromatase-inhibitor therapy was given (adjuvant therapy vs first-line therapy) and participating center. Patients are randomized to 1 of 3 treatment arms.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 750 patients (250 per treatment arm) will be accrued for this study.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast
Metastatic disease must be measurable or evaluable
Relapsed or progressed during prior treatment with single-agent nonsteroidal aromatase inhibitor (NSAI)*, meeting either of the following criteria:
Achieved an objective complete response, partial response, or stable disease that lasted ≥ 6 months after prior first-line therapy with NSAI for locally advanced or metastatic disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Postmenopausal, as defined by 1 of the following criteria:
Performance status
Life expectancy
Hematopoietic
Platelet count ≥ 100,000/mm^3
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Other
Concurrent bisphosphonates for bone metastases allowed provided bisphosphonate therapy has been established for ≥ 6 months
United Kingdom, England | |
Institute of Cancer Research - Sutton | Recruiting |
Sutton, England, United Kingdom, SM2 5NG | |
Contact: Gill Coombes 44-20-8722-4039 | |
Royal Marsden - London | Recruiting |
London, England, United Kingdom, SW3 6JJ | |
Contact: Stephen R. D. Johnston, MD, PhD, FRCP 44-20-7808-2748 |
Study Chair: | Stephen R. D. Johnston, MD, PhD, FRCP | Royal Marsden - London |
Study ID Numbers: | CDR0000448616, ICR-CTSU-SOFEA, EU-20531, SSA-04Q200635, ISRCTN44195747, MREC-03677, EUDRACT-2004-000093-30 |
Study First Received: | November 11, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00253422 |
Health Authority: | Unspecified |
recurrent breast cancer stage IV breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Anastrozole Skin Diseases Fulvestrant Disease Progression |
Breast Neoplasms Exemestane Breast Diseases Recurrence |
Estrogen Antagonists Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Enzyme Inhibitors Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors |