EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
This study, called EXActDNA-003, is investigating a new blood test for people with high-risk, early-stage breast cancer. The test looks for tiny bits of cancer DNA, called circulating tumour DNA (ctDNA), in your blood. The main goal is to see if finding this DNA can tell us more about how your cancer might behave after you've had chemotherapy. If you join, you would be planning to have chemotherapy for your breast cancer and be happy to give blood and tissue samples. Researchers will then follow your health for up to five and a half years to understand the results of these tests better. It's a way to explore new tools that might help doctors in the future.
At a glance
What is this study about?
This research study, known as EXActDNA-003, is focused on exploring a new way to monitor breast cancer, especially for those with a higher risk of the cancer returning. It's designed to see if a special blood test, which can detect tiny fragments of cancer-related DNA (called circulating tumour DNA or ctDNA), can give doctors more information about how your body is responding to treatment and how you might do in the long run.
Imagine your cancer cells as leaving tiny clues behind in your bloodstream. This test tries to find those clues. The study will follow people who are going to have chemotherapy for their early-stage breast cancer. By regularly checking their blood, researchers hope to learn if finding these DNA clues can help predict outcomes. This could potentially lead to new ways doctors manage breast cancer in the future, helping them tailor treatments more precisely.
It's important to remember that this is a research study. While promising, the tests used here are still being investigated and are not yet a standard part of breast cancer care. The information gathered will help us understand if this type of test could be useful for patients in the future.
Key takeaways
- This study explores a new blood test (ctDNA) for high-risk breast cancer.
- It aims to understand if ctDNA can predict how cancer might behave after chemotherapy.
- Participation involves providing blood and tissue samples over several years.
- The study doesn't change your planned cancer treatment.
- Results could help doctors better manage breast cancer in the future.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old and have been diagnosed with invasive breast cancer. Your doctors must be planning for you to have chemotherapy before any surgery (this is called neoadjuvant therapy).
Additionally, your breast cancer needs to meet certain criteria, such as being a specific size (at least 2.1 cm) or having features that indicate it's a higher-risk type. For example, if your cancer has spread to nearby lymph nodes, or if it's a particular aggressive type like triple-negative or HER2-positive. If your cancer is hormone receptor positive and HER2-negative, it might qualify if it's high-grade, has a high Ki67 level, or a high genomic risk score.
You wouldn't be able to join if you have cancer that has already spread to other parts of your body (metastatic disease), or if you've already started your planned chemotherapy. Also, if you've had certain other types of cancer or surgeries very recently, or if you're pregnant, you wouldn't be eligible. The study team will review all your detailed medical information to see if you're a good fit.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years or older?
- Do you have invasive breast cancer?
- Are you planned to have chemotherapy before surgery (neoadjuvant chemotherapy)?
- Is your tumour size at least 2.1 cm or meet other higher-risk criteria?
- Are you willing to give blood and tissue samples?
- Do you NOT have cancer that has spread to other parts of your body (metastatic disease)?
What does participation involve?
If you decide to take part in this study, you'll first need to carefully read and sign a consent form. While involved, you'll be asked to provide small tissue samples from your original breast or lymph node biopsy. You'll also need to give blood samples regularly – about 2.5 tablespoons each time – throughout the study period. These blood draws will happen at specific times, usually coinciding with your regular medical appointments.
The study will not involve any new medications or treatments beyond what your doctor would normally recommend for your breast cancer. Instead, it focuses on these special tests using your blood and tissue. The main commitment is attending your scheduled appointments for blood tests and allowing the research team to follow your health journey for up to five and a half years. This follow-up will largely involve collecting information from your routine medical care.
Potential risks and benefits
Locations (58)
- Katmai Oncology Group - AnchorageVerified postcodeAnchorage, United States· Recruiting
- Stanford Cancer InstituteVerified postcodePalo Alto, United States· Recruiting
- Harbor-UCLA Medical Center - Hematology / OncologyVerified postcodeTorrance, United States· Recruiting
- Kaiser Permanente Medical CenterVerified postcodeVallejo, United States· Recruiting
- UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer CenterVerified postcodeAurora, United States· Recruiting
- AdventHealth East Altamonte Oncology and HematologyVerified postcodeAltamonte Springs, United States· Recruiting
- Mount Sinai Medical - Comprehensive Cancer CenterVerified postcodeMiami Beach, United States· Recruiting
- Baptist Cancer Care - PlantationVerified postcodePlantation, United States· Recruiting
- St. Joseph's Women's HospitalVerified postcodeTampa, United States· Recruiting
- Rush Cancer CenterVerified postcodeChicago, United States· Recruiting
- Deaconess Chancellor Center for OncologyVerified postcodeNewburgh, United States· Recruiting
- University of Kansas Cancer CenterVerified postcodeWestwood, United States· Recruiting
Common questions
What is ctDNA?
ctDNA stands for circulating tumour DNA. It's tiny bits of genetic material released by cancer cells that can be found in your blood.
Will this study change my breast cancer treatment?
No, this study will not change the chemotherapy or any other treatment your doctor plans for your breast cancer. It's purely for research purposes.
How long will I be in this study?
Researchers will follow your health for up to five and a half years to gather enough information from the blood tests.
Are there any extra doctor visits needed for this study?
Your blood draws for the study will usually be taken during your routine medical appointments, so you shouldn't need many extra visits just for the study itself.
What happens to my samples?
Your tissue and blood samples will be used to create and run specific tests for ctDNA analysis by the researchers, to better understand breast cancer.
How to find out more
NSABP Department of Site and Study Management Department of Site and Study Management
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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