Ignite Creation Date:
2024-05-06 @ 1:50 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01904903
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2013-07-17
Brief Title:
Cardiac Safety Study in Patients With HER2 Breast Cancer
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
SAFE-HEaRt A Pilot Study Assessing the Cardiac SAFEty of HER2 Targeted Therapy in Patients With HER2 Positive Breast Cancer and Reduced Left Ventricular Function
Status:
COMPLETED
Status Verified Date:
2022-05
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:
SAFE-HEaRt
Brief Summary:
HER2 positive breast cancer cells have more HER2 receptor a protein on the surface of cells than normal breast cells Approximately 30 of patients with breast cancer have HER2 positive breast cancer Before HER2 targeted therapies ie treatments that directly block the receptor HER2 were developed patients with HER2 positive breast cancer had a very aggressive form of disease With the use of trastuzumab an anticancer drug that directly targets the receptor HER2 and more recently pertuzumab and ado-trastuzumab emtansine patients are able to live longer and have better control of their cancer
Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and for this reason these treatments were only studied and approved for patients with normal heart function
In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast cancer and mildly decreased heart function along with concomitant evaluation by a heart doctor called cardiologist and appropriate medications to strengthen the heart We will do frequent monitoring of the heart function with a test called echocardiogram that will give us a detailed picture of the heart We will also draw blood along with routine blood tests to try to understand why some patients develop heart problems and others do not The study will take a maximum of 12 months and patients will be monitored for 6 additional months
We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast cancer and mildly decreased heart function ie LVEF between 40 and 50 while on appropriate heart medications
Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and for this reason these treatments were only studied and approved for patients with normal heart function
In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast cancer and mildly decreased heart function along with concomitant evaluation by a heart doctor called cardiologist and appropriate medications to strengthen the heart We will do frequent monitoring of the heart function with a test called echocardiogram that will give us a detailed picture of the heart We will also draw blood along with routine blood tests to try to understand why some patients develop heart problems and others do not The study will take a maximum of 12 months and patients will be monitored for 6 additional months
We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast cancer and mildly decreased heart function ie LVEF between 40 and 50 while on appropriate heart medications
Detailed Description:
Title A pilot study evaluating the cardiac safety of HER2 targeted therapy non-lapatinib in patients with HER2 positive breast cancer and reduced left ventricular function Phase Pilot study Study Duration 4 years with up to 5 additional years of follow up Study Centers 3 centers will be participating MedStar Washington Hospital Center MWHC MedStar Georgetown University Hospital MGUH and Memorial Sloan Kettering Cancer Center MSKCC Primary Objective To evaluate the cardiac safety of HER2 targeted therapy non-lapatinib in patients with HER2 positive breast cancer and reduced left ventricular ejection fraction LVEF when given concomitantly with cardiac treatment
Secondary Objectives
To evaluate time to development of cardiac event or asymptomatic worsening of cardiac function
Absolute changes in LVEF
Delays in HER2 therapy attributed to cardiac causes
Correlations between echocardiographic myocardial strain
cTnI and hs-cTnT at baseline and over time with cardiac events and asymptomatic worsening of cardiac function Sample size 30 patients
Diagnosis and Main Inclusion Criteria
HER2 positive breast cancer stage I-IV
Mildly decreased cardiac function LVEF between 40 and 49 prior to or while receiving non-lapatinib HER2 targeted therapy
Cardiac Intervention
- Beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses
Oncology study Products Doses Routes Regimens
Trastuzumab loading dose of 8 mgkg IV followed by a maintenance dose of 6 mgkg every 3 weeks or a loading dose of 4 mgkg followed by a maintenance dose of 2 mgkg every week
Pertuzumab loading dose of 840 mg IV followed by 420 mg IV every 3 weeks administered concomitantly with trastuzumab
Ado-trastuzumab emtansine 36mgkg IV every three weeks Note both trastuzumab and pertuzumab may be administered alone or in combination with other systemic or radiation therapy
Duration of drug administration Maximum of 12 months
Secondary Objectives
To evaluate time to development of cardiac event or asymptomatic worsening of cardiac function
Absolute changes in LVEF
Delays in HER2 therapy attributed to cardiac causes
Correlations between echocardiographic myocardial strain
cTnI and hs-cTnT at baseline and over time with cardiac events and asymptomatic worsening of cardiac function Sample size 30 patients
Diagnosis and Main Inclusion Criteria
HER2 positive breast cancer stage I-IV
Mildly decreased cardiac function LVEF between 40 and 49 prior to or while receiving non-lapatinib HER2 targeted therapy
Cardiac Intervention
- Beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses
Oncology study Products Doses Routes Regimens
Trastuzumab loading dose of 8 mgkg IV followed by a maintenance dose of 6 mgkg every 3 weeks or a loading dose of 4 mgkg followed by a maintenance dose of 2 mgkg every week
Pertuzumab loading dose of 840 mg IV followed by 420 mg IV every 3 weeks administered concomitantly with trastuzumab
Ado-trastuzumab emtansine 36mgkg IV every three weeks Note both trastuzumab and pertuzumab may be administered alone or in combination with other systemic or radiation therapy
Duration of drug administration Maximum of 12 months
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