Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470704
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2007-05-07
Brief Title:
Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive Metastatic Breast Cancer
Sponsor:
Nancy Lin MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase 2 Study of Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast We are also studying whether positron emission tomography PETCT scans can predict which participants will benefit from the study treatment Finally we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin and to the combination of Herceptin plus lapatinib Lapatinib is a compound that may stop cancer cells from growing Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer
Detailed Description:
Participants will be asked to undergo a biopsy of an area of the body where the cancer has spread
Participants will be given a study medication-dosing calendar for each treatment cycle Each treatment cycle lasts four weeks during which time you will be taking lapatinib once per day
Participants will receive Herceptin once every week or once every 3 weeks through a vein
During all treatment cycles a physical exam will be performed and questions about the participants general health will be asked Blood tests including chemistry and hematology will be performed to measure additional effect of the study drug and disease status Photographs may be taken of the tumor to assess the response of the tumor to treatment
CT scans will be repeated every 8 weeks to assess the effect of the study treatment on the cancer Either a MUGA scan or echocardiogram will be performed 8 weeks and 16 weeks after the participant starts the study treatment
Participants will remain on this research study for as long as they are benefiting from the study treatment
Participants will be given a study medication-dosing calendar for each treatment cycle Each treatment cycle lasts four weeks during which time you will be taking lapatinib once per day
Participants will receive Herceptin once every week or once every 3 weeks through a vein
During all treatment cycles a physical exam will be performed and questions about the participants general health will be asked Blood tests including chemistry and hematology will be performed to measure additional effect of the study drug and disease status Photographs may be taken of the tumor to assess the response of the tumor to treatment
CT scans will be repeated every 8 weeks to assess the effect of the study treatment on the cancer Either a MUGA scan or echocardiogram will be performed 8 weeks and 16 weeks after the participant starts the study treatment
Participants will remain on this research study for as long as they are benefiting from the study treatment
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