Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Progression-free survival at 1 year [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
- Tumor response as measured by RECIST [ Time Frame: from randomisation ] [ Designated as safety issue: No ]
- Duration of response as measured by RECIST [ Time Frame: response duration ] [ Designated as safety issue: No ]
- Safety as measured by CTC v2.0 [ Time Frame: from randomization ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2003|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Experimental: Arimidex + Iressa® 250 mg
Arimidex + Iressa® 250 mg Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal
|Drug: anastrozole Drug: gefitinib|
Active Comparator: Arimidex + Placebo
Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal
- 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.
|Ziekenhuis Netwerk Antwerpen Middelheim|
|Antwerpen, Belgium, B-2020|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Algemeen Ziekenhuis Sint-Augustinus|
|Wilrijk, Belgium, 2610|
|Bordeaux, France, 33076|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 CX|
|Universitair Medisch Centrum St. Radboud - Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Institute of Oncology - Ljubljana|
|Ljubljana, Slovenia, Sl-1000|
|Edinburgh Cancer Centre at Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Study Chair:||Martine J. Piccart, MD, PhD||Institut Jules Bordet|