ctDNA MRD Test for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on detecting tiny amounts of cancer DNA in the blood of individuals with high-risk, early breast cancer who are about to start chemotherapy. The main goal is to determine if circulating tumor DNA (ctDNA) can predict treatment effectiveness or cancer recurrence. Participants must have a confirmed breast cancer diagnosis, a tumor size of at least 2.1 cm, and plan to receive chemotherapy. This trial aims to enhance researchers' understanding of cancer behavior and treatment response over time. As a Phase 2 trial, it measures treatment effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer care.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the ctDNA MRD test is safe?
Research has shown that ctDNA MRD testing in early-stage breast cancer patients has been the focus of several studies. These studies primarily assess the test's ability to detect cancer recurrence, rather than concentrating on safety concerns. In these studies, ctDNA testing analyzes blood samples for tiny pieces of tumor DNA.
Regarding safety, ctDNA testing is generally easy on patients, requiring only a blood sample, a common and low-risk procedure. No major side effects have been reported from the testing itself. Although the FDA has not approved the test for all uses, ongoing research aims to fully understand its potential and safety in various contexts. While the test appears safe based on current knowledge, further studies are underway to provide detailed safety information.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it focuses on detecting molecular residual disease (MRD) in high-risk early breast cancer. Unlike traditional methods that rely on imaging or tissue biopsies to monitor cancer, MRD detection uses advanced DNA analysis to identify tiny amounts of cancer-related genetic material in the blood. This approach could potentially offer more precise and earlier detection of cancer recurrence, allowing for timely interventions and personalized treatment plans. By identifying cancer at a molecular level, this technique aims to improve outcomes and provide a clearer picture of how well treatments are working.
What evidence suggests that the ctDNA MRD test is effective for high-risk early breast cancer?
Studies have shown that ctDNA (circulating tumor DNA) tests can help detect the early return of breast cancer. In early-stage triple-negative breast cancer, one test identified the cancer's return 71% of the time before regular check-ups could detect it. This test provided an average of 5 months' warning before any clinical signs appeared. Research suggests that ctDNA is promising for spotting cancer's return at the DNA level before symptoms show. These early warnings can be crucial for making timely treatment decisions in high-risk breast cancer cases. Participants in this trial with high-risk early breast cancer will undergo evaluation using the ctDNA MRD test to assess its effectiveness in providing early detection of cancer recurrence.36789
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy
Participants undergo chemotherapy for high-risk early breast cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment, including ctDNA analysis
What Are the Treatments Tested in This Trial?
Interventions
- ctDNA MRD test
Find a Clinic Near You
Who Is Running the Clinical Trial?
Exact Sciences Corporation
Lead Sponsor
NSABP Foundation Inc
Collaborator