Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390455
Status:
COMPLETED
Last Update Posted:
2019-12-20
First Post:
2006-10-18
Brief Title:
Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors A Randomized Double-Blind Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib GW572016 for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-11
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 III trial studies fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive Estrogen can cause the growth of breast cancer cells Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To compare the effect in terms of progression free survival of the antiestrogen fulvestrant alone with fulvestrant administered in combination with the dual-kinase inhibitor lapatinib for postmenopausal women with estrogen receptor ER andor progesterone receptor PgR positive advanced breast cancer
SECONDARY OBJECTIVES
I To compare the effects of fulvestrant alone with fulvestrant and lapatinib on other clinical endpoints including response rate response and stable disease rate complete response CR partial response PR stable disease 6 months duration of response overall survival symptom checklist scores and toxicity
II To define predictive markers of clinical activity among women receiving fulvestrant with or without lapatinib
III To determine if the clinical benefits for combination of hormonal and growth factor inhibitor therapy are most pronounced in women whose tumors express higher levels of ER epidermal growth factor receptor EGFR human epidermal growth factor receptor 2 HER2 phosphorylated protein kinase B pAkt andor phosphorylated mitogen-activated protein kinase 12 pERK12
IV To serologically determine if HER2 extracellular domain ECD and EGFR ECD levels can identify patients with a greater likelihood of response and clinical benefit to fulvestrant with or without lapatinib
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive lapatinib ditosylate orally PO once daily QD on days 1-28 and fulvestrant intramuscularly IM on days 1 and 15 of course 1 and on day 1 of each subsequent course
ARM II Patients receive placebo PO QD on days 1-28 and fulvestrant as in Arm I
In both arms treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for 2 years and then annually for 3 years
I To compare the effect in terms of progression free survival of the antiestrogen fulvestrant alone with fulvestrant administered in combination with the dual-kinase inhibitor lapatinib for postmenopausal women with estrogen receptor ER andor progesterone receptor PgR positive advanced breast cancer
SECONDARY OBJECTIVES
I To compare the effects of fulvestrant alone with fulvestrant and lapatinib on other clinical endpoints including response rate response and stable disease rate complete response CR partial response PR stable disease 6 months duration of response overall survival symptom checklist scores and toxicity
II To define predictive markers of clinical activity among women receiving fulvestrant with or without lapatinib
III To determine if the clinical benefits for combination of hormonal and growth factor inhibitor therapy are most pronounced in women whose tumors express higher levels of ER epidermal growth factor receptor EGFR human epidermal growth factor receptor 2 HER2 phosphorylated protein kinase B pAkt andor phosphorylated mitogen-activated protein kinase 12 pERK12
IV To serologically determine if HER2 extracellular domain ECD and EGFR ECD levels can identify patients with a greater likelihood of response and clinical benefit to fulvestrant with or without lapatinib
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive lapatinib ditosylate orally PO once daily QD on days 1-28 and fulvestrant intramuscularly IM on days 1 and 15 of course 1 and on day 1 of each subsequent course
ARM II Patients receive placebo PO QD on days 1-28 and fulvestrant as in Arm I
In both arms treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for 2 years and then annually for 3 years
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 |
|---|---|---|---|
| U10CA031946 | NIH | CTEP | httpsreporternihgovquickSearchU10CA031946 |
| NCI-2009-00475 | REGISTRY | None | None |
| CDR0000510452 | None | None | None |
| CALGB-40302 | OTHER | None | None |
| CALGB-40302 | OTHER | None | None |
| U10CA180821 | NIH | None | None |