Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02226276
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2014-08-25
Brief Title:
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Pilot Study of 64Cu-DOTA-Trastuzumab Positron Emission Tomography in Treatment of Advanced HER2 Positive Breast Cancer With the Antibody Drug Conjugate Ado-trastuzumab Emtansine
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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 pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid DOTA-trastuzumab positron emission tomography PET works in predicting response to treatment with ado-trastuzumab emtansine in patients with human epidermal growth factor receptor 2 HER2 positive breast cancer that has spread to other places in the body Copper Cu 64-DOTA-trastuzumab is a chemotherapy drug trastuzumab attached to a radioactive substance Diagnostic procedures using PET may allow scanners to take pictures of where the drug travels in the body and may help doctors identify which patients may benefit from treatment with ado-trastuzumab emtansine
Detailed Description:
PRIMARY OBJECTIVES
I Correlate uptake of 64Cu-DOTA-trastuzumab copper Cu 64-DOTA-trastuzumab PET by individual tumors with subsequent tumor response to ado-trastuzumab emtansine as assessed by serial 18F-fludeoxyglucose FDG fludeoxyglucose F 18PET-computed tomography CT
II Compare tumor uptake of 64Cu-DOTA-trastuzumab PET between patients who do and patients who do not respond to ado-trastuzumab emtansine
III Obtain tumor tissue for subsequent assessment of the presence of putative molecular mechanisms of resistance MMRs to ado-trastuzumab emtansine When funding becomes available those samples will be used to explore the correlation between the presence of MMRs as assessed by histopathology and tumor response to ado-trastuzumab emtansine both in univariate analysis and in combination with tumor uptake of 64Cu-DOTA-trastuzumab as measured with PETCT
OUTLINE
Patients undergo whole body fludeoxyglucose F 18 PETCT Patients then receive trastuzumab intravenously IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV and then undergo PET scans at 24 and 48 hours Patients then receive ado-trastuzumab emtansine IV every 3 weeks until complete response or disease progression at the discretion of the treating oncologist Patients undergo restaging by whole body fludeoxyglucose F 18 PETCT every 6 weeks for 1 year after initiation of treatment until disease progression
After completion of study treatment patients are followed up for 1 year
I Correlate uptake of 64Cu-DOTA-trastuzumab copper Cu 64-DOTA-trastuzumab PET by individual tumors with subsequent tumor response to ado-trastuzumab emtansine as assessed by serial 18F-fludeoxyglucose FDG fludeoxyglucose F 18PET-computed tomography CT
II Compare tumor uptake of 64Cu-DOTA-trastuzumab PET between patients who do and patients who do not respond to ado-trastuzumab emtansine
III Obtain tumor tissue for subsequent assessment of the presence of putative molecular mechanisms of resistance MMRs to ado-trastuzumab emtansine When funding becomes available those samples will be used to explore the correlation between the presence of MMRs as assessed by histopathology and tumor response to ado-trastuzumab emtansine both in univariate analysis and in combination with tumor uptake of 64Cu-DOTA-trastuzumab as measured with PETCT
OUTLINE
Patients undergo whole body fludeoxyglucose F 18 PETCT Patients then receive trastuzumab intravenously IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV and then undergo PET scans at 24 and 48 hours Patients then receive ado-trastuzumab emtansine IV every 3 weeks until complete response or disease progression at the discretion of the treating oncologist Patients undergo restaging by whole body fludeoxyglucose F 18 PETCT every 6 weeks for 1 year after initiation of treatment until disease progression
After completion of study treatment patients are followed up for 1 year
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-2014-01812 | REGISTRY | None | None |
| 14099 | OTHER | City of Hope Medical Center | None |