Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118157
Status:
COMPLETED
Last Update Posted:
2017-12-04
First Post:
2005-07-08
Brief Title:
Lapatinib and Tamoxifen in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Tamoxifen
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of GW572016 and Tamoxifen in Patients With Metastatic Breast Cancer Resistant to Single-Agent Tamoxifen
Status:
COMPLETED
Status Verified Date:
2017-10
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 phase II trial studies how well giving lapatinib ditosylate together with tamoxifen citrate works in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or to other areas of the body and did not respond to previous treatment with tamoxifen citrate Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Estrogen can cause the growth of breast cancer cells Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells Sometimes when tamoxifen citrate is given it does not stop the growth of tumor cells The tumor is said to be resistant to tamoxifen citrate Giving lapatinib ditosylate together with tamoxifen citrate may reduce drug resistance and allow the tumor cells to be killed
Detailed Description:
PRIMARY OBJECTIVES
I To determine the response rate complete response and partial response of tamoxifen tamoxifen citrate and GW572016 lapatinib ditosylate in women with hormone refractory metastatic breast cancer
II To describe the changes in phosphorylation of epidermal growth factor receptor EGFR human EGFR 2 her2 protein B kinase AKT kinase mitogen activated protein kinase MAPK estrogen receptor ER-Serine Ser 118 and ER-Ser167 in tumor tissue after administration of tamoxifen and GW572016
OUTLINE
Patients receive lapatinib ditosylate orally PO daily and tamoxifen citrate PO daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 1 month and then every 3 months thereafter
I To determine the response rate complete response and partial response of tamoxifen tamoxifen citrate and GW572016 lapatinib ditosylate in women with hormone refractory metastatic breast cancer
II To describe the changes in phosphorylation of epidermal growth factor receptor EGFR human EGFR 2 her2 protein B kinase AKT kinase mitogen activated protein kinase MAPK estrogen receptor ER-Serine Ser 118 and ER-Ser167 in tumor tissue after administration of tamoxifen and GW572016
OUTLINE
Patients receive lapatinib ditosylate orally PO daily and tamoxifen citrate PO daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 1 month and then every 3 months thereafter
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 |
|---|---|---|---|
| NCI-2009-00080 | REGISTRY | None | None |
| CDR0000433388 | None | None | None |
| C-2876 | OTHER | None | None |
| 6724 | OTHER | None | None |
| P30CA022453 | NIH | None | None |
| U01CA062487 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062487 |