Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00057941|
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : May 6, 2011
Last Update Posted : May 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor-positive Breast Cancer Progesterone Receptor-positive Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer||Drug: anastrozole Drug: gefitinib Drug: fulvestrant Other: laboratory biomarker analysis||Phase 2|
I. Evaluate the antitumor activity of anastrozole given in combination with the EGFR tyrosine kinase inhibitor ZD1839, and of fulvestrant given in combination with the EGFR tyrosine kinase inhibitor ZD1839.
II. Evaluate the safety of anastrozole given in combination with ZD1839 and fulvestrant given in combination with ZD1839.
III. Evaluate the interaction of biological characteristics that predict for response of breast cancer to treatment with anastrozole and ZD1839 and with fulvestrant and ZD1839.
OUTLINE: This is a randomized, open-label study. Patients are stratified according to prior hormonal therapy (yes vs. no) and dominant site of disease (soft tissue/lymph nodes vs. bone vs. visceral). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
Arm II: Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
Courses in both arms repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||148 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial of Combination Anastrozole (NSC #719344) Plus ZD1839 (Iressa, NSC #715055, IND #61187) and of Combination Fulvestrant (NSC #719276) Plus ZD1839 in the Treatment of Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: Arm I (anastrozole, gefitinib)
Patients receive oral anastrozole and oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
Experimental: Arm II (fulvestrant, gefitinib)
Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
- Clinical Benefit Rate [ Time Frame: assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years ]Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease <30% or increase <20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057941
|United States, Massachusetts|
|Eastern Cooperative Oncology Group|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Robert Carlson||Eastern Cooperative Oncology Group|