Study on T-DXd Combinations for HER2-positive Metastatic Breast Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04538742
This clinical trial is exploring the safety and effectiveness of combining trastuzumab deruxtecan (T-DXd) with other cancer treatments for patients with HER2-positive metastatic breast cancer.
Patient Parameters
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Program Overview
The DESTINY-Breast07 study aims to test how safe and effective trastuzumab deruxtecan (T-DXd) is when used with other cancer drugs in patients with HER2-positive metastatic breast cancer. The study will be conducted in two parts: the first part will determine the best dose, and the second part will expand the study to more patients using that dose. The study includes patients with advanced or metastatic HER2-positive breast cancer, including those with stable brain metastases.
Description
This study is designed to test the safety and effectiveness of T-DXd in combination with other cancer drugs. It will be conducted in two phases: a dose-finding phase to determine the best dose, and a dose-expansion phase to test this dose in more patients. The study focuses on patients with HER2-positive advanced or metastatic breast cancer, including those with stable brain metastases. In the first part, patients who have already received treatment for metastatic cancer will be enrolled. In the second part, patients who have not yet received treatment for advanced or metastatic cancer will be included.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have breast cancer that is advanced or metastatic and cannot be treated with the intent to cure.
- Cancer must be HER2-positive based on specific tests.
- Cancer may be hormone receptor-positive or negative.
- Must provide a tumor sample for testing.
- Must be in good overall health with an ECOG performance status of 0 or 1.
- For Part 1: Must have experienced disease progression after previous treatment and have had at least one prior treatment for metastatic cancer.
- For Part 2 (Modules 0-5): No prior treatment for advanced/metastatic cancer allowed.
- For Part 2 (Modules 6 and 7): Zero or one prior treatment for advanced/metastatic cancer allowed.
- For Modules 0-5: No brain metastases or stable brain metastases.
- For Modules 6 and 7: Untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed.
Exclusion Criteria
- Uncontrolled or serious heart disease.
- Lung conditions like ILD/pneumonitis that required steroids or cannot be ruled out.
- Serious lung illnesses.
- Uncontrolled infections needing IV treatment.
- Spinal cord compression or history of cancer spread to the brain lining.
- Previous treatment with certain immune therapies or specific cancer drugs.
- For Modules 0-5: Untreated brain metastases.
- For Modules 6 and 7: Ongoing use of high-dose steroids for brain metastases or brain lesions needing immediate treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 33901 | Fort Myers | Florida |
| Research Site | 33705 | St. Petersburg | Florida |
| Research Site | 11725 | Commack | New York |
| Research Site | 10604 | Harrison | New York |
| Research Site | 10016 | New York | New York |
| Research Site | 10065 | New York | New York |
| Research Site | 43219 | Columbus | Ohio |
| Research Site | 37203 | Nashville | Tennessee |
| Research Site | 76104 | Fort Worth | Texas |
| Research Site | 22031 | Fairfax | Virginia |
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