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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066378 |
Purpose
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by reducing the production of estrogen. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining anastrozole with gefitinib may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of anastrozole with or without gefitinib in treating postmenopausal women who have metastatic or locally recurrent breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: anastrozole Drug: gefitinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | An EORTC Randomized, Double Blind, Placebo-Controlled, Phase II Multi-Center Trial Of Anastrozole (Arimidex) In Combination With ZD 1839 (Iressa) Or Placebo In Patients With Advanced Breast Cancer |
| Estimated Enrollment: | 108 |
| Study Start Date: | May 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, dominant site of metastatic disease (bone alone vs other), prior chemotherapy (no vs yes), stage (metastatic vs locally recurrent), and measurability (measurable vs evaluable). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 108 patients (54 per treatment arm) will be accrued for this study.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, defined by any of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No clinically active interstitial lung disease
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent administration of any of the following drugs:
Concurrent bisphosphonate therapy for the treatment and prevention of bony metastases is allowed provided therapy was initiated prior to study entry
Contacts and Locations| Belgium | |
| Algemeen Ziekenhuis Sint-Augustinus | |
| Wilrijk, Belgium, 2610 | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Ziekenhuis Netwerk Antwerpen Middelheim | |
| Antwerpen, Belgium, B-2020 | |
| France | |
| Centre Henri Becquerel | |
| Rouen, France, 76038 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Netherlands | |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | |
| Amsterdam, Netherlands, 1066 CX | |
| Universitair Medisch Centrum St. Radboud - Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Slovenia | |
| Institute of Oncology - Ljubljana | |
| Ljubljana, Slovenia, Sl-1000 | |
| United Kingdom, Scotland | |
| Edinburgh Cancer Centre at Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Investigator: | Martine J. Piccart-Gebhart, MD, PhD | Institut Jules Bordet |
More Information
| Study ID Numbers: | CDR0000315629, EORTC-10021, IDBBC-10021 |
| Study First Received: | August 6, 2003 |
| Last Updated: | December 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00066378 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
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Anastrozole Antineoplastic Agents, Hormonal Skin Diseases Breast Neoplasms Aromatase Inhibitors |
Protein Kinase Inhibitors Gefitinib Breast Diseases Recurrence |
|
Anastrozole Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Breast Neoplasms Enzyme Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors Gefitinib Breast Diseases |