Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00049062|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 21, 2013
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in treating postmenopausal women who have metastatic breast cancer that has not responded to hormone therapy.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: anastrozole Drug: gefitinib||Phase 2|
- Determine the antitumor activity of anastrozole and ZD 1839, as measured by objective response (partial or complete) or stable disease at 6 months, in post-menopausal women with estrogen receptor-positive, hormone refractory, metastatic breast cancer.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Correlate molecular markers with clinical benefit in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients are stratified according to prior objective response to endocrine therapy (yes vs no).
Patients receive oral anastrozole once daily alone for 2 weeks. Patients then receive oral anastrozole and oral ZD 1839 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month and then monthly thereafter.
PROJECTED ACCRUAL: A total of 36-78 patients (18-39 per stratum) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II And Biologic Correlative Study Investigating ARIMIDEX In Combination With IRESSA (ZD1839) In Post-Menopausal Patients With Estrogen Receptor-Positive Metastatic Breast Carcinoma Who Have Previously Failed Hormonal Therapy|
|Study Start Date :||September 2002|
|Primary Completion Date :||October 2007|
|Study Completion Date :||October 2007|
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): NCT00049062
|United States, Texas|
|Cancer Therapy and Research Center|
|San Antonio, Texas, United States, 78229|
|Study Chair:||Eric K. Rowinsky, MD||Cancer Therapy and Research Center, Texas|