Anastrozole & ZD1839 Compared With Fulvestrant & ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer
This randomized phase II trial is studying how well giving gefitinib together with anastrozole works compared to giving gefitinib together with fulvestrant in treating postmenopausal women with recurrent or metastatic breast cancer. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. Gefitinib (ZD1839) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether gefitinib is more effective when combined with anastrozole or fulvestrant in treating breast cancer.
Estrogen Receptor-positive Breast Cancer
Progesterone Receptor-positive Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Other: laboratory biomarker analysis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2003|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
Given orallyDrug: gefitinib
Given orallyOther: 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.
Given orallyDrug: fulvestrant
Given intramuscularlyOther: laboratory biomarker analysis
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.
|United States, Massachusetts|
|Eastern Cooperative Oncology Group|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Robert Carlson||Eastern Cooperative Oncology Group|