Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An IDBBC Single Arm Phase II Trial Evaluating The Activity Of Iressa (ZD1839) In Metastatic Breast Cancer Patients Pretreated With An Antiestrogen And A Non-Steroidal Aromatase Inhibitor (Anastrozole Or Letrozole)|
|Study Start Date:||May 2003|
|Primary Completion Date:||January 2004 (Final data collection date for primary outcome measure)|
- Determine the clinical benefit rate, defined as complete response, partial response, or stable disease after at least 24 weeks, in patients receiving gefitinib for metastatic breast cancer who progressed after prior antiestrogen and nonsteroidal aromatase inhibitor therapy.
- Determine the best overall response rate of patients treated with this drug.
- Determine the progression-free survival of patients treated with this drug.
- Determine the duration of response in patients treated with this drug.
- Determine the safety of this drug in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients who go off study in the absence of disease progression are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Study Chair:||Martine J. Piccart-Gebhart, MD, PhD||Institut Jules Bordet|