Study on Patritumab Deruxtecan and Trastuzumab Deruxtecan for Advanced Breast Cancer
Sponsor: Daiichi Sankyo
ClinicalTrials ID:NCT07701941
This clinical trial is testing a combination of two drugs, Patritumab Deruxtecan and Trastuzumab Deruxtecan, to see if they are safe and effective in treating patients with advanced breast cancer that is hormone receptor-positive and has low levels of HER2 protein.
Patient Parameters
| Parameter | Options |
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Program Overview
The main goal of this study is to evaluate the safety and effectiveness of combining two drugs, HER3-DXd and T-DXd, in treating patients with advanced breast cancer that cannot be surgically removed or has spread to other parts of the body. The study focuses on patients whose cancer is hormone receptor-positive and has low or very low levels of HER2 protein.
Eligibility Criteria
Inclusion Criteria
- Have breast cancer that cannot be surgically removed or has spread to other parts of the body.
- Cancer must be hormone receptor-positive, meaning it has estrogen or progesterone receptors.
- Cancer must have low or very low levels of HER2 protein, as determined by specific tests.
- Provide a tumor sample from a recent biopsy or a new biopsy if needed.
- Cancer must have shown progression after previous treatment.
- Must have tried hormone therapy for advanced cancer and it is no longer effective.
- Have previously used a CDK4/6 inhibitor.
- If eligible for other targeted therapies, must have tried them unless not available or suitable.
- No prior chemotherapy for advanced breast cancer, but previous chemotherapy for early-stage cancer is allowed.
- Be in good overall health with a performance status of 0 or 1.
- Have at least one measurable tumor on a scan.
- Have adequate blood cell counts and organ function based on recent tests.
Exclusion Criteria
- Have previously been treated with anti-HER3 drugs or similar therapies.
- Have a history of lung diseases like interstitial lung disease or pneumonitis.
- Are taking high doses of steroids or other immunosuppressive drugs.
- Have active or untreated brain or spinal cord metastases.
- Have not had enough time since previous treatments before starting the study.
- Have uncontrolled heart conditions or significant heart disease.
- Have had another active cancer within the last 3 years, except for certain skin or cervical cancers.
- Have unresolved side effects from previous cancer treatments.
- Have allergies to the study drugs or their ingredients.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute | 90048 | Los Angeles | California |
| Stanford Medicine Cancer Center | 94305 | Stanford | California |
| University of Colorado Denver - School of Medicine - Anschutz Medical Campus | 80045 | Aurora | Colorado |
| Yale University School of Medicine - Yale Cancer Center | 06510 | New Haven | Connecticut |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02216 | Boston | Massachusetts |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Compass Oncology - Rose Quarter Cancer Center | 97227 | Portland | Oregon |
| The West Cancer Center | 38138 | Memphis | Tennessee |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
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