Study on Ado-Trastuzumab Emtansine for Cancers with HER2 Genetic Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04439110
This clinical trial is testing a targeted treatment called ado-trastuzumab emtansine for patients with cancers that have a specific genetic change known as HER2 amplification. The study aims to see if this treatment can shrink tumors or stop them from growing.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring the effects of a drug called ado-trastuzumab emtansine on cancers with a genetic change called HER2 amplification. Ado-trastuzumab emtansine is a targeted therapy that combines a monoclonal antibody, trastuzumab, with a chemotherapy drug, DM1. The antibody attaches to HER2 receptors on cancer cells, delivering the chemotherapy directly to them to help kill the cancer cells. Researchers want to find out if this treatment can reduce the size of tumors or prevent them from growing.
Description
The main goal of this study is to see how many patients with advanced cancers respond to the treatment with ado-trastuzumab emtansine. Researchers will also look at how many patients are still alive and have not seen their cancer progress after six months of treatment. They will study how long it takes for the cancer to progress or for the patient to pass away. Additionally, the study will explore other factors that might predict how well the treatment works, using various tests and imaging techniques.
Patients in the study will receive ado-trastuzumab emtansine through an IV infusion over 30 to 90 minutes on the first day of each 21-day cycle. This will continue as long as the cancer does not progress and the patient can tolerate the treatment. After finishing the treatment, patients will have follow-up visits every three months for the first two years, and then every six months in the third year.
Eligibility Criteria
Inclusion Criteria
- Must meet the eligibility criteria of the main MATCH Protocol before joining this study.
- Cancer must have a HER2 amplification greater than 7, confirmed by specific genetic testing.
- Hemoglobin level must be at least 9.0 g/dL, which can be achieved with a blood transfusion if necessary.
- Can be on certain blood thinners or low-dose aspirin, but not on long-acting anti-platelet drugs like clopidogrel.
- Must have a recent ECG showing no major heart rhythm issues.
- Must have a recent heart function test showing a left ventricular ejection fraction of 50% or higher.
- Women of childbearing potential and men must agree to use effective birth control during the study and for seven months after completing the study.
Exclusion Criteria
- Cannot have breast cancer or gastric/gastroesophageal junction cancer.
- Cannot have an allergy to ado-trastuzumab emtansine or similar drugs.
- Cannot have severe peripheral neuropathy (nerve damage) that affects daily activities.
- Cannot have previously received certain treatments, including trastuzumab, pertuzumab, ado-trastuzumab emtansine, or similar investigational drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.