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Dato-DXd for Triple-negative Breast Cancer
Study Summary
This trial is testing a new cancer treatment against the current best treatment for a particular type of aggressive breast cancer, to see if the new treatment is more effective and has fewer side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have an active tuberculosis infection.My cancer is HER2 negative according to specific testing guidelines.I had cancer before, but it was treated successfully over 3 years ago and is unlikely to come back.You are expected to live for at least 12 weeks.I have not been in any drug studies or had severe reactions to certain drugs recently.I am using birth control as per my local guidelines.Pembrolizumab is not approved in my country.I have a tumor that can be measured and has not been treated with radiation.I haven't had any cancer, except for skin cancer, in the last 5 years.I have had a condition where my lymphocytes grow abnormally.I have signed a consent form for optional genetic research.I have a history of cancer.I do not have significant heart issues, lung problems, or severe eye diseases.My physical ability has been stable or better for the last 2 weeks.I do not have any infections needing IV treatment.My organs and bone marrow are functioning well.I haven't had certain cancer treatments, major surgery, or live vaccines recently.I haven't had chemotherapy or targeted therapy for my advanced breast cancer.I still have side effects from cancer treatment, except for hair loss, that haven't improved.I haven't had chemotherapy or other cancer treatments for advanced breast cancer.My physical ability hasn't worsened in the last 2 weeks.My HIV infection is not well controlled.My triple-negative breast cancer is inoperable or has spread and cannot be cured.I do not have active or uncontrolled hepatitis B or C.I am 18 years old or older.My breast cancer is PD-L1 negative or has returned after PD-1/PD-L1 treatment.
- Group 1: Dato-DXd
- Group 2: Investigator's Choice of Chemotherapy (ICC)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you please elaborate on any potential risks associated with Dato-DXd?
"Dato-DXd is classified as a Phase 3 trial medication, so it has received a 3 for safety. This decision was made because there is both efficacy and safety data available."
How many different facilities are responsible for administering this clinical trial?
"There are a total of 48 clinical trial sites for this medication, which are situated in locations such as Greenfield Park, Montreal, and Miami. If you are selected for the trial, it would be ideal to choose a location close to you to reduce travel demands."
How many people fit the criteria to be a part of this test group?
"The information available on clinicaltrials.gov indicates that this trial is still enrolling patients. This study was first announced on May 16th, 2022 and was last updated on October 26th, 2022. The researchers are looking for 600 individuals to participate across 48 different sites."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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