Study on Treating ADC-Refractory Breast Cancer with Dato-DXd or T-DXd: TRADE DXd
Sponsor: Ana C Garrido-Castro, MD
ClinicalTrials ID:NCT06533826
This clinical trial is testing the safety and effectiveness of two investigational drugs, datopotamab deruxtecan and trastuzumab deruxtecan, in treating HER2-low metastatic breast cancer. The study aims to find out if using these drugs in sequence can help control the cancer.
Patient Parameters
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Program Overview
The purpose of this study is to test if two investigational drugs, trastuzumab deruxtecan and datopotamab deruxtecan, can effectively treat HER2-low metastatic breast cancer. These drugs are a type of treatment called antibody drug conjugates (ADCs), which are designed to target and kill cancer cells. The study will explore if using these drugs one after the other can improve treatment outcomes.
Description
This study involves two investigational drugs, datopotamab deruxtecan and trastuzumab deruxtecan, for treating HER2-low metastatic breast cancer. Participants will be randomly assigned to receive one of these drugs first. If the cancer progresses, they will switch to the other drug. The study aims to see if this sequence of treatments can better control the cancer.
Participants will be divided into groups based on their hormone receptor (HR) status, which can be either positive or negative. The study will monitor the effectiveness of the treatments and any side effects. Participants will undergo various tests, including blood tests, scans, and biopsies, to track their progress.
The study is expected to include about 357 participants. AstraZeneca is providing the study drugs and funding for this research. Participants will continue receiving the study treatment as long as it is beneficial and will be followed up every six months after the treatment ends.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed invasive breast cancer that is either locally advanced and cannot be removed by surgery or has spread to other parts of the body.
- Must have HER2-low breast cancer, as determined by specific tests.
- Must have measurable disease according to standard criteria.
- Must be willing to undergo tissue biopsies if the tumor is safely accessible.
- Must have received certain prior treatments, including endocrine therapy and chemotherapy, depending on hormone receptor status.
- Must be 18 years or older.
- Must have good overall health and organ function.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
- Men must agree to use contraception if they have partners who can become pregnant.
- Must be able to understand and agree to the study requirements.
Exclusion Criteria
- Cannot be using other investigational drugs for cancer treatment.
- Cannot have received certain types of chemotherapy targeting topoisomerase I, except as specified.
- Cannot have received a live vaccine within 30 days before starting the study.
- Cannot have significant eye disease or severe allergies to the study drugs.
- Cannot have had major surgery within two weeks before starting the study.
- Cannot have uncontrolled illnesses or infections.
- Cannot have a history of lung disease that required steroids or current lung disease.
- Cannot have certain heart conditions or recent heart procedures.
- Cannot have a history of another cancer unless it has been treated and is not expected to return.
- Cannot have uncontrolled HIV, hepatitis B, or hepatitis C infections.
- Cannot be pregnant, breastfeeding, or planning to become pregnant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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