Study Comparing Trastuzumab Deruxtecan and Trastuzumab Emtansine for High-Risk HER2-Positive Breast Cancer After Initial Therapy
Sponsor: Daiichi Sankyo
ClinicalTrials ID:NCT04622319
This clinical trial is exploring whether trastuzumab deruxtecan (T-DXd) is more effective than trastuzumab emtansine (T-DM1) in treating patients with high-risk HER2-positive breast cancer that remains after initial therapy. The study aims to find better treatment options for these patients to reduce the risk of cancer returning.
Patient Parameters
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Program Overview
This study focuses on patients with HER2-positive breast cancer who still have cancer cells in their breast or lymph nodes after receiving initial treatment. These patients are at a higher risk of the cancer coming back. The trial will compare two treatments, trastuzumab deruxtecan (T-DXd) and trastuzumab emtansine (T-DM1), to see which one is more effective in preventing the cancer from returning and ensuring patients remain disease-free.
Description
The trial is designed to compare two treatments for patients with HER2-positive breast cancer who have remaining cancer cells after initial therapy. These patients are considered high-risk because their cancer did not completely respond to the first round of treatment. The main goal is to see which treatment, trastuzumab deruxtecan (T-DXd) or trastuzumab emtansine (T-DM1), helps patients stay free from invasive cancer longer. The study will also look at overall disease-free survival.
Participants must have completed initial therapy, including chemotherapy and HER2-targeted treatment, and have had surgery to remove any visible cancer. The study will monitor how well each treatment works in preventing the cancer from coming back and will assess the safety of the treatments.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older.
- Diagnosed with HER2-positive breast cancer, confirmed by specific lab tests.
- Have invasive breast cancer that remains after initial therapy, with certain high-risk features.
- Completed initial therapy, including at least 16 weeks of treatment with chemotherapy and HER2-targeted drugs before surgery.
- Surgery must have removed all visible cancer.
- Randomization must occur within 12 weeks after surgery.
- Known hormone receptor status.
- Heart function must be adequate, with a left ventricular ejection fraction (LVEF) of 50% or higher.
- General health status must be good, with an ECOG performance status of 0 or 1.
- Must have adequate organ function based on recent tests.
Exclusion Criteria
- Stage IV (metastatic) breast cancer.
- History of any other breast cancer except for certain non-invasive types.
- Visible cancer remaining after initial therapy and surgery.
- Previous treatment with T-DXd, T-DM1, or similar drugs.
- History of high doses of certain chemotherapy drugs (anthracyclines).
- History of other cancers within the last 5 years, with some exceptions.
- History of lung disease requiring steroids or current lung issues on a CT scan.
- Known lung problems from other illnesses, such as severe asthma or COPD.
- Autoimmune or inflammatory disorders affecting the lungs.
- Recent heart attack or severe heart failure.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The Oncology Institute of Hope & Innovation | 92801 | Anaheim | California |
| Kaiser Permanente | 92806 | Anaheim | California |
| Kaiser Permanente | 91706 | Baldwin Park | California |
| Kaiser Permanente | 90706 | Bellflower | California |
| Kaiser Permanente | 92335 | Fontana | California |
| Orange Coast Blood and Cancer Care | 92708 | Fountain Valley | California |
| Kaiser Permanente | 90710 | Harbor City | California |
| Kaiser Permanente | 92618 | Irvine | California |
| Long Beach Memorial TCI | 90806 | Long Beach | California |
| Kaiser Permanente | 90027 | Los Angeles | California |
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