Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
- Registration Number
- NCT00066378
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Compare the 1 year antitumor activity of anastrozole with vs without gefitinib, in terms of progression-free survival, in postmenopausal women with metastatic or locally recurrent advanced breast cancer.
* Compare the objective tumor response and duration of tumor response in patients treated with these regimens.
* Compare the progression-free survival of patients treated with these regimens.
* Compare the safety of these regimens in these patients.
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.
* Arm I: Patients receive oral anastrozole and oral gefitinib once daily.
* Arm II: Patients receive oral anastrozole and an oral placebo once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 71
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arimidex + Iressa® 250 mg anastrozole Arimidex + Iressa® 250 mg Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal Arimidex + Iressa® 250 mg gefitinib Arimidex + Iressa® 250 mg Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal Arimidex + Placebo anastrozole Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal
- Primary Outcome Measures
Name Time Method Progression-free survival at 1 year at 1 year
- Secondary Outcome Measures
Name Time Method Tumor response as measured by RECIST from randomisation Duration of response as measured by RECIST response duration Safety as measured by CTC v2.0 from randomization
Trial Locations
- Locations (9)
Institut Jules Bordet
🇧🇪Brussels, Belgium
Algemeen Ziekenhuis Sint-Augustinus
🇧🇪Wilrijk, Belgium
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerpen, Belgium
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands
Institute of Oncology - Ljubljana
🇸🇮Ljubljana, Slovenia
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Institut Bergonie
🇫🇷Bordeaux, France
Centre Henri Becquerel
🇫🇷Rouen, France
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands