Study Comparing Trastuzumab Deruxtecan to Chemotherapy for HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04494425
This clinical trial is testing whether the drug trastuzumab deruxtecan is more effective and safer than standard chemotherapy for patients with HER2-low, hormone receptor positive metastatic breast cancer that has worsened after hormone therapy.
Patient Parameters
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Program Overview
The study is designed to find out if trastuzumab deruxtecan can help patients with HER2-low, hormone receptor positive metastatic breast cancer live longer or have a better quality of life compared to those receiving standard chemotherapy. It focuses on patients whose cancer has progressed despite previous hormone treatments.
Description
This study is for patients with advanced or metastatic breast cancer that is hormone receptor positive and HER2-low. Participants should have experienced cancer progression after at least two hormone therapy treatments for metastatic disease, or within six months of starting a first-line treatment that included hormone therapy and a CDK4/6 inhibitor. The trial will compare the effects of trastuzumab deruxtecan with standard chemotherapy chosen by the doctor. Researchers aim to see if trastuzumab deruxtecan can help patients live longer without their cancer worsening, or simply live longer, while also assessing the impact on quality of life.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have advanced or metastatic breast cancer.
- Cancer must be HER2-low or negative, as confirmed by tests.
- Cancer must be hormone receptor positive in the metastatic setting.
- No previous chemotherapy for advanced or metastatic breast cancer.
- Must have enough tumor samples for HER2 testing.
- Cancer must have worsened within 6 months of starting first-line treatment with hormone therapy and a CDK4/6 inhibitor, or after at least two previous hormone therapy treatments for metastatic cancer.
- Must have adequate organ and bone marrow function as defined by the study.
Exclusion Criteria
- Cannot receive any of the chemotherapy options available in the study.
- Have significant lung illnesses.
- Have uncontrolled heart disease or infections.
- Have a history of lung disease that required steroids, or current lung issues that cannot be ruled out by imaging.
- Have spinal cord compression or active brain metastases.
- Have participated in a previous trastuzumab deruxtecan study.
- Are currently enrolled in another clinical study, unless it is non-interventional.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85259 | Scottsdale | Arizona |
| Research Site | 72762 | Springdale | Arkansas |
| Research Site | 91010 | Duarte | California |
| Research Site | 90017 | Los Angeles | California |
| Research Site | 80045 | Aurora | Colorado |
| Research Site | 80228 | Lakewood | Colorado |
| Research Site | 20016 | Washington D.C. | District of Columbia |
| Research Site | 32224 | Jacksonville | Florida |
| Research Site | 66160 | Kansas City | Kansas |
| Research Site | 40202 | Louisville | Kentucky |
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