Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503841
Status:
TERMINATED
Last Update Posted:
2019-04-30
First Post:
2007-07-17
Brief Title:
Erlotinib in Treating Women Undergoing Surgery For Stage I Stage II or Stage III Breast Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
A Pilot Study of the Effect of Erlotinib Tarceva on Biomarkers in Estrogen Receptor Negative Breast Cancer Expressing the Epidermal Growth Factor Receptor and Interleukin 1α
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
All enrolled participants were screen failures no data were collected for outcome measures
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PURPOSE This clinical trial is studying how well erlotinib works in treating women undergoing surgery for stage I stage II or stage III breast cancer
PURPOSE This clinical trial is studying how well erlotinib works in treating women undergoing surgery for stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Primary
To estimate the effect of erlotinib hydrochloride on expression of interleukin IL-1α in patients with estrogen receptor ER--negative EGFR-positive and IL-1α-positive breast cancer
Secondary
To estimate the effect of erlotinib hydrochloride on expression of nuclear NF-κB and amphiregulin AR in patients with ER-negative EGFR-positive and IL-1α-positive breast cancer
To estimate the effect of erlotinib on tumor cell proliferation Ki67 and apoptosis TUNEL
To estimate the rates of IL-1α nuclear NF-κB and AR expression in patients with ER-negative EGFR-positive breast cancer
To follow the clinical course of patients with resectable ER-negative EGFR-positive and IL-1α-positive breast cancer
To assess the toxicity of a 15-day regimen of daily oral administration of erlotinib hydrochloride in participants with ER-negative EGFR-positive and IL-1α-positive breast cancer
OUTLINE This is an open-label pilot study Patients are stratified according to HER2 status positive vs negative
Patients receive oral erlotinib hydrochloride once daily on days -14 to 0 in the absence of disease progression or unacceptable toxicity
Patients undergo surgery on day 0
Tissue samples are collected at baseline and examined for expression of estrogen receptor progesterone receptor HER2 EGFR interleukin IL-1α amphiregulin and NF-kB Tissue samples collected at surgery are examined for IL-1α NF-kB and amphiregulin by IHC
Following surgery patients will be contacted 1 week post-surgery 1 day or 1 week post-withdrawal from study 1 day by phone call or clinic visit to assess toxicity After that patients will be followed and treated according to standard of care practices If patients choose to follow-up with an oncologist outside of our institution they or their oncologist will be contacted every 6 months for updated information on their conditions
Primary
To estimate the effect of erlotinib hydrochloride on expression of interleukin IL-1α in patients with estrogen receptor ER--negative EGFR-positive and IL-1α-positive breast cancer
Secondary
To estimate the effect of erlotinib hydrochloride on expression of nuclear NF-κB and amphiregulin AR in patients with ER-negative EGFR-positive and IL-1α-positive breast cancer
To estimate the effect of erlotinib on tumor cell proliferation Ki67 and apoptosis TUNEL
To estimate the rates of IL-1α nuclear NF-κB and AR expression in patients with ER-negative EGFR-positive breast cancer
To follow the clinical course of patients with resectable ER-negative EGFR-positive and IL-1α-positive breast cancer
To assess the toxicity of a 15-day regimen of daily oral administration of erlotinib hydrochloride in participants with ER-negative EGFR-positive and IL-1α-positive breast cancer
OUTLINE This is an open-label pilot study Patients are stratified according to HER2 status positive vs negative
Patients receive oral erlotinib hydrochloride once daily on days -14 to 0 in the absence of disease progression or unacceptable toxicity
Patients undergo surgery on day 0
Tissue samples are collected at baseline and examined for expression of estrogen receptor progesterone receptor HER2 EGFR interleukin IL-1α amphiregulin and NF-kB Tissue samples collected at surgery are examined for IL-1α NF-kB and amphiregulin by IHC
Following surgery patients will be contacted 1 week post-surgery 1 day or 1 week post-withdrawal from study 1 day by phone call or clinic visit to assess toxicity After that patients will be followed and treated according to standard of care practices If patients choose to follow-up with an oncologist outside of our institution they or their oncologist will be contacted every 6 months for updated information on their conditions
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 |
|---|---|---|---|
| WSU-2006-138 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |