Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411788
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2006-12-14
Brief Title:
A Phase II Study of Rapamycin and Trastuzumab for Patients With HER-2 Receptor Positive Metastatic Breast Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Phase II Study of Rapamycin Rapamune Sirolimus and Trastuzumab Herceptin for Patients With HER-2 Receptor Positive Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-08
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:
Rapamune generic name Sirolimus is a drug that has been approved by the Food and Drug Administration government for use in patients receiving a kidney transplant to prevent the patients body from rejecting the transplanted kidney It has shown antitumor effects in the laboratory but has not been approved at this time for the treatment of cancer Herceptin is a new form of chemotherapy that has been approved by the Food and Drug Administration for the treatment of breast cancer
This study is designed to evaluate the effect and safety of combining Rapamune and Herceptin on breast cancer Rapamune and Herceptin are being combined because results from our laboratory studies suggest that the combination of the two drugs is superior to either drug used alone Results from laboratory studies performed at other institutions suggest that adding Rapamune to Herceptin may also reverse the resistance to Herceptin Although there has been extensive experience using Herceptin alone and Rapamune alone in human subjects the combination of Herceptin and Rapamune has not been previously evaluated In addition we hope to better understand how these treatments work against an individual womans tumor by analyzing tissue samples before and during treatment
This study is designed to evaluate the effect and safety of combining Rapamune and Herceptin on breast cancer Rapamune and Herceptin are being combined because results from our laboratory studies suggest that the combination of the two drugs is superior to either drug used alone Results from laboratory studies performed at other institutions suggest that adding Rapamune to Herceptin may also reverse the resistance to Herceptin Although there has been extensive experience using Herceptin alone and Rapamune alone in human subjects the combination of Herceptin and Rapamune has not been previously evaluated In addition we hope to better understand how these treatments work against an individual womans tumor by analyzing tissue samples before and during treatment
Detailed Description:
None
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