Study on Trastuzumab Deruxtecan (T-DXd) Alone or with THP Compared to Standard Treatment for HER2-positive Early Breast Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT05113251
This clinical trial is evaluating the effectiveness and safety of a new drug, trastuzumab deruxtecan (T-DXd), used alone or in combination with other treatments, for patients with high-risk, HER2-positive early-stage breast cancer.
Patient Parameters
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Program Overview
The study aims to find out how well trastuzumab deruxtecan (T-DXd) works and how safe it is when used before surgery in patients with high-risk, HER2-positive early breast cancer that has not spread to other parts of the body. Participants will be randomly assigned to one of three groups: receiving T-DXd alone, T-DXd followed by a combination of other drugs (THP), or the standard treatment (ddAC-THP).
Description
This study focuses on patients with high-risk HER2-positive early-stage breast cancer. The goal is to evaluate how effective and safe T-DXd is when given before surgery. Participants will be divided into three groups: one group will receive T-DXd alone, another group will receive T-DXd followed by a combination of drugs called THP, and the third group will receive the standard treatment, which includes drugs ddAC and THP.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have HER2-positive early breast cancer confirmed by lab tests, with specific stages as determined by imaging tests.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have good organ and bone marrow function.
- Have a heart function of at least 50% as measured by specific tests within 28 days before starting the study.
- Provide a tissue sample for HER2 testing, either as a tissue block or a set of slides, unless otherwise discussed with the study doctor.
Exclusion Criteria
- Have had invasive breast cancer before.
- Have stage IV breast cancer.
- Have had any other primary cancer within the last 3 years, except for certain skin cancers or treated in situ diseases.
- Have a history of ductal carcinoma in situ (DCIS) unless treated with mastectomy over 5 years ago.
- Have or have had lung diseases like interstitial lung disease or pneumonitis.
- Have received any systemic therapy for breast cancer before.
- Have been treated with certain chemotherapy drugs like anthracyclines, cyclophosphamide, or taxanes for any cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 72762 | Springdale | Arkansas |
| Research Site | 90211 | Beverly Hills | California |
| Research Site | 91204 | Glendale | California |
| Research Site | 90720 | Los Alamitos | California |
| Research Site | 92868 | Orange | California |
| Research Site | 06510 | New Haven | Connecticut |
| Research Site | 46804 | Fort Wayne | Indiana |
| Research Site | 40503 | Lexington | Kentucky |
| Research Site | 40202 | Louisville | Kentucky |
| Research Site | 71101 | Shreveport | Louisiana |
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