Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy
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|ClinicalTrials.gov Identifier: NCT00066339|
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : July 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: gefitinib||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Masking:||None (Open Label)|
|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|
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): NCT00066339
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Study Chair:||Martine J. Piccart-Gebhart, MD, PhD||Jules Bordet Institute|