Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225758
Status:
TERMINATED
Last Update Posted:
2018-07-27
First Post:
2005-09-22
Brief Title:
Lapatinib in Metastatic Breast Cancer Resistant to Hormone Therapy
Sponsor:
Gary Schwartz
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Lapatinib in Endocrine-Resistant Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Two thirds or more of breast cancers are dependent on estrogen for growth We use a number of estrogen-blocking medicines for treatment of metastatic breast cancer The treatment response to these agents is unpredictable however and approximately one-third of patients with metastatic breast cancer with receptors for estrogen or progesterone have no benefit from hormonal therapy Nearly all patients with metastatic breast cancer will eventually become resistant to hormonal therapy despite the fact that the hormone receptors are still present
Some cells make a different class of growth factor receptor called the Epidermal Growth Factor Receptor There is a growing body of experimental evidence showing that breast cancer cells that make Epidermal Growth Factor Receptors are more resistant to hormonal therapy and have a poorer prognosis Several investigators have found that the Epidermal Growth Factor Receptor can activate the estrogen receptor even in the presence of estrogen-blocking drugs Growth of these cells can be slowed by blockade of both Epidermal Growth Factor Receptor signaling and estrogen-receptor signaling Lapatinib is a small molecule which can inhibit two different forms of the Epidermal Growth Factor Receptor It has been studied in people with a number of different cancers including breast cancer and a safe dose and its common side effects have been defined
Our hypothesis is that the Epidermal Growth Factor Receptor is the dominant receptor pathway used by breast cancers in our patients with hormone-resistant tumors Drugs like lapatinib which block several forms of the Epidermal Growth Factor Receptor would best be able to reverse resistance to hormonal agents
Some cells make a different class of growth factor receptor called the Epidermal Growth Factor Receptor There is a growing body of experimental evidence showing that breast cancer cells that make Epidermal Growth Factor Receptors are more resistant to hormonal therapy and have a poorer prognosis Several investigators have found that the Epidermal Growth Factor Receptor can activate the estrogen receptor even in the presence of estrogen-blocking drugs Growth of these cells can be slowed by blockade of both Epidermal Growth Factor Receptor signaling and estrogen-receptor signaling Lapatinib is a small molecule which can inhibit two different forms of the Epidermal Growth Factor Receptor It has been studied in people with a number of different cancers including breast cancer and a safe dose and its common side effects have been defined
Our hypothesis is that the Epidermal Growth Factor Receptor is the dominant receptor pathway used by breast cancers in our patients with hormone-resistant tumors Drugs like lapatinib which block several forms of the Epidermal Growth Factor Receptor would best be able to reverse resistance to hormonal agents
Detailed Description:
All patients must have stopped their endocrine two to four weeks or longer prior to entry on study Upon enrollment patients will begin lapatinib at 1500 mg once a day orally The original endocrine therapy will resume two weeks later The lapatinib will be continued for a maximum of 26 weeks
A history physical examination blood counts and chemistries will be done at baseline and at regular intervals through the course of the study A CT scan and bone scan will be done prior to treatment and at weeks 14 and 26 Assays for plasma DNA will be performed on blood sampled at baseline and at multiple time points throughout the course of treatment Percutaneous biopsies will be taken in selected patients with accessible disease 72 hours or less prior to the start of lapatinib and again 13-15 days and 27-29 days following the start of lapatinib The day 13-15 biopsy will be done just prior to the resumption of the patients endocrine therapy Assays for phospho-ERK phospho-Akt Cyclin D1 Ki-67 and IRS-1 will be performed by conventional immunohistochemistry on the biopsied tissue
A history physical examination blood counts and chemistries will be done at baseline and at regular intervals through the course of the study A CT scan and bone scan will be done prior to treatment and at weeks 14 and 26 Assays for plasma DNA will be performed on blood sampled at baseline and at multiple time points throughout the course of treatment Percutaneous biopsies will be taken in selected patients with accessible disease 72 hours or less prior to the start of lapatinib and again 13-15 days and 27-29 days following the start of lapatinib The day 13-15 biopsy will be done just prior to the resumption of the patients endocrine therapy Assays for phospho-ERK phospho-Akt Cyclin D1 Ki-67 and IRS-1 will be performed by conventional immunohistochemistry on the biopsied tissue
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