Study of Patritumab Deruxtecan with Other Cancer Drugs for HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06686394
This clinical trial is exploring whether the drug patritumab deruxtecan, combined with other cancer treatments, can help treat HER2 positive breast cancer that has spread to other parts of the body and cannot be removed by surgery.
Patient Parameters
| Parameter | Options |
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Program Overview
Researchers are studying if patritumab deruxtecan (MK-1022) can help treat certain types of breast cancer that are HER2 positive and have spread or cannot be surgically removed. The study aims to find out how safe the drug is, how well patients can tolerate it, and how effective it is in shrinking or eliminating the cancer.
Description
This study is being conducted in several countries, including Canada, the United Kingdom, Israel, Japan, South Korea, and the USA. It aims to evaluate the safety and effectiveness of patritumab deruxtecan in combination with other cancer treatments for patients with HER2 positive breast cancer that has spread or cannot be surgically removed. The study will look at how well patients tolerate the treatment and how many patients experience a reduction in their cancer.
Eligibility Criteria
Inclusion Criteria
- Have HER2 positive breast cancer that is locally advanced and cannot be removed by surgery, or has spread to other parts of the body.
- If you have HIV, it must be well-controlled with medication.
- If you have hepatitis B, you must have been on antiviral treatment for at least 4 weeks and have an undetectable viral load.
- If you have had hepatitis C, your viral load must be undetectable.
- Be in good overall health with an ECOG performance status of 0 to 1.
Arm 1:
- Have received 2 to 5 previous treatments for HER2 positive cancer that has spread or is locally advanced.
- Have had cancer progression after previous treatment with trastuzumab deruxtecan (T-DXd).
Arm 2:
- Have received no more than 5 previous treatments for HER2 positive cancer that has spread or is locally advanced.
Arm 3:
- Have had cancer progression after T-DXd treatment and received up to 3 previous treatments for HER2 positive cancer that has spread or is locally advanced. T-DXd must be the most recent treatment before joining the study.
Exclusion Criteria
- Have uncontrolled or serious heart disease.
- Have a history of lung disease that required steroids or currently have lung disease.
- Have severe breathing problems.
- Have a history or current evidence of cancer spreading to the brain or spinal cord.
- Have significant eye disease affecting the cornea.
- Have an ongoing uncontrolled infection.
- If you have HIV, you must not have a history of Kaposi's sarcoma or Multicentric Castleman's Disease.
- Have another cancer that is progressing or required treatment in the past 3 years.
- Have evidence of cancer spreading to the brain or spinal cord.
- Have an active infection needing treatment.
- Have both active hepatitis B and C infections.
- Have had major surgery less than 28 days ago.
Arm 3 ONLY:
- Have previously been treated with tucatinib, lapatinib, neratinib, or any investigational HER2-targeted drugs in the advanced cancer setting.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Rutgers Cancer Institute of New Jersey ( Site 0052) | 08901 | New Brunswick | New Jersey |
| Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053) | 29605 | Greenville | South Carolina |
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