Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00066378|
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : October 24, 2013
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 or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: anastrozole Drug: gefitinib||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||August 2007|
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
Active Comparator: Arimidex + Placebo
Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal
- Progression-free survival at 1 year [ Time Frame: at 1 year ]
- Tumor response as measured by RECIST [ Time Frame: from randomisation ]
- Duration of response as measured by RECIST [ Time Frame: response duration ]
- Safety as measured by CTC v2.0 [ Time Frame: from randomization ]
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): NCT00066378
|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||Jules Bordet Institute|