Study on Trastuzumab and Pertuzumab for Patients with HER2 Gene Amplified Tumors (MATCH - Subprotocol J)
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06136897
This clinical trial is testing the effectiveness of two drugs, trastuzumab and pertuzumab, in treating cancers with higher than normal copies of the HER2 gene, excluding breast, gastric, and colorectal cancers. These drugs are designed to target and block signals that help cancer cells grow.
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Program Overview
This study is exploring how well the drugs trastuzumab and pertuzumab work together to treat cancers that have an increased number of HER2 genes, except for breast, gastric, and colorectal cancers. These drugs are a type of targeted therapy that attach to the HER2 protein on cancer cells, blocking signals that promote cell growth and marking the cells for destruction by the immune system. Trastuzumab is already used for certain HER2-positive cancers, and research suggests that using both drugs together might be more effective than using one alone.
Description
The main goal of this study is to see how many patients experience a reduction in their cancer with the combination of trastuzumab and pertuzumab. Researchers also want to know how many patients are alive and have no disease progression after six months of treatment. They will also study how long it takes for the disease to progress or for the patient to pass away. Additionally, the study will look for other markers that might predict how well the treatment works or why it might not work, using various tests and imaging.
Patients will receive pertuzumab and trastuzumab through an IV every three weeks, as long as the cancer does not progress and there are no severe side effects. Throughout the trial, patients will have regular scans, heart tests, and blood samples taken. After finishing the treatment, patients will have follow-up visits every three months for two years, then every six months for one year.
This study is part of the MATCH Screening Trial, which involves specific eligibility criteria and testing protocols. For more details, refer to the MATCH Screening Protocol (NCT02465060).
Eligibility Criteria
Inclusion Criteria
- Must meet eligibility criteria from the MATCH Master Protocol before joining this treatment study.
- Must have HER2 amplification or another specific genetic change as identified by the MATCH Master Protocol.
- Must have a recent ECG with no significant heart issues.
- Must have a recent heart scan showing normal heart function.
- Cannot have breast, gastric, or colorectal cancer.
- Cannot be allergic to trastuzumab or pertuzumab.
- Cannot have had previous treatments targeting HER2, like trastuzumab or pertuzumab.
- Women who can become pregnant and men with partners who can become pregnant must use effective birth control during and for seven months after treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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