Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057941
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2003-04-07
Brief Title:
Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
PRIMARY OBJECTIVES
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 tissuelymph 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
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 tissuelymph 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E4101 | OTHER | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2012-03148 | REGISTRY | None | None |
| CDR0000285631 | None | None | None |
| U10CA021115 | NIH | None | None |
| E4101 | OTHER | None | None |