DNA Testing for Early-Stage Breast Cancer

Not currently recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Ductal carcinoma in situ, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to track remaining cancer cells in early-stage breast cancer patients using DNA from tumor cells found in the blood, known as circulating tumor DNA-based minimal residual disease detection. The goal is to determine if this method can identify patients who might need additional treatment after surgery to prevent cancer recurrence. Participants will have their blood and, in some cases, tumor tissue tested for these DNA fragments at various points during and after their standard treatments. Individuals with stage I-III breast cancer who are willing to provide blood and tumor samples may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future cancer care.

Do I have to stop taking my current medications for this 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 ctDNA MRD detection is safe for early-stage breast cancer patients?

Research has shown that using circulating tumor DNA (ctDNA) tests to detect minimal residual disease (MRD) is generally safe for patients. ctDNA tests identify tiny pieces of DNA in the blood from dying tumor cells.

Studies have found that patients can easily handle ctDNA testing, which usually doesn't cause side effects since it only involves a blood test. This method has been used successfully in other stages and types of cancer, suggesting it is safe for early-stage breast cancer as well.

No reports of major problems related to the ctDNA test itself have emerged, providing reassurance for those considering joining a trial using this method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using circulating tumor DNA (ctDNA) to detect minimal residual disease in early-stage breast cancer patients. Unlike traditional methods like imaging and biopsies that can miss microscopic cancer cells, this method analyzes fragments of tumor DNA in the blood, potentially catching recurrence much earlier. This could allow for more timely interventions and personalized treatment plans, possibly improving outcomes for patients.

What evidence suggests that ctDNA MRD detection is effective for early-stage breast cancer?

Research has shown that using a blood test to detect tiny amounts of cancer DNA, known as circulating tumor DNA (ctDNA), holds promise for early-stage breast cancer. In this trial, participants will be divided into two cohorts to undergo blood collection for ctDNA testing at various points in their treatment journey. One study found that this test effectively detects small traces of cancer that might predict recurrence. Another study highlighted a specific test called Guardant Reveal, which can identify cancer without requiring surgery. This method could help doctors decide if additional treatment is needed after surgery and standard therapy. Overall, ctDNA testing offers a new way to track breast cancer and improve patient outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Jose G Bazan

Principal Investigator

City of Hope Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with early-stage breast cancer. It's focused on those who have undergone surgery and are receiving standard treatment. The goal is to see if testing for tiny amounts of tumor DNA in the blood can help decide if extra therapy would be beneficial.

Inclusion Criteria

Willingness to provide blood samples, archival tumor tissue sample, tumor tissue sample from resection/surgery, and permit medical record review

Fall into one of the following categories defined below: Cohort 1, Subgroup A or B OR Cohort 2

I have been diagnosed with stage I-III breast cancer.

Exclusion Criteria

An employee who is under the direct/indirect supervision of the principal investigator (PI)/a co-investigator/the study manager

A direct study team member

My condition is ductal carcinoma in situ.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive standard of care neoadjuvant chemotherapy and undergo blood sample collection for ctDNA testing

Varies per standard of care

Blood samples collected at 14-21 days post cycle 1, day 1 of chemotherapy

Surgery

Participants undergo curative-intent surgical resection and blood sample collection for ctDNA testing

1 day

1 visit (in-person)

Adjuvant Therapy

Participants may receive adjuvant radiation therapy and/or systemic therapy with blood sample collection for ctDNA testing

Varies per standard of care

Blood samples collected at 1-2 weeks after radiation therapy and 2-4 weeks after systemic therapy

Follow-up

Participants are monitored for ctDNA levels and recurrence-free survival up to 3 years after definitive treatment

3 years

Every 3 months for 1 year, then every 6 months up to year 3

What Are the Treatments Tested in This Trial?

Interventions

• Circulating Tumor DNA Based Minimal Residual Disease Detection

Trial Overview Researchers are studying whether tracking circulating tumor DNA (ctDNA) can effectively detect minimal residual disease (MRD) in patients with early-stage breast cancer. This involves surveys, collecting biological samples, and reviewing electronic health records.

How Is the Trial Designed?

Group I: Cohort 2 (blood collection for ctDNA testing -2) Experimental Treatment 3 Interventions

Patients undergo collection of blood samples for ctDNA testing on the day of SOC surgery, at 3-6 weeks after SOC surgery, at 1-2 weeks after SOC adjuvant radiation therapy (if receiving), at 2-4 weeks after SOC adjuvant systemic therapy (if receiving), every 3 months for 1 year after surgery, and then every 6 months up to year 3 after surgery. Patients may also undergo collection of tumor tissue during SOC surgery on study.

Group II: Cohort 1 (blood collection for ctDNA testing - 1) Experimental Treatment 3 Interventions

Patients undergo collection of blood samples for ctDNA testing at 14-21 days post cycle 1, day 1 of SOC neoadjuvant chemotherapy, on the day of SOC surgery, at 3-6 weeks after SOC surgery, at 1-2 weeks after SOC adjuvant radiation therapy (if receiving), at 2-4 weeks after SOC adjuvant systemic therapy (if receiving), every 3 months for 1 year after surgery, and then every 6 months up to year 3 after surgery. Patients may also undergo collection of tumor tissue during SOC surgery on study.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07136493

Circulating Tumor DNA Based Minimal Residual Disease ... This results in very large clinical trials required to demonstrate a modest benefit from treatment. Using ctDNA MRD testing in early-stage breast cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11982450/

Detection of minimal residual disease and prediction of ... This study demonstrates the feasibility of MRD detection in EBC using a plasma-only multiomic ctDNA-based approach.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.1052

Circulating tumor DNA (ctDNA)-based minimal residual ... Our study demonstrates clinically significant performance of a tissue-free MRD test, Guardant Reveal, as a potential non-invasive monitoring tool.

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1634859/full

Liquid clues: tracking early-stage breast cancer with ctDNA Here, we will review available data supporting the utility of ctDNA in non-metastatic breast cancer with a focus on its role in monitoring ...

5. nature.com nature.com/articles/s41523-025-00811-1

ctDNA, genomics, and equity in breast cancer care In breast cancer, ctDNA has shown promise in both metastatic and early-stage settings. However, its application and benefits have not been ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12420329/

Liquid clues: tracking early-stage breast cancer with ctDNA Circulating tumor DNA (ctDNA) is a testing modality that has several potential applications in the management of non-metastatic breast cancer.

7. nature.com nature.com/articles/s41523-024-00653-3

Use of ctDNA in early breast cancer: analytical validity and ... For instance, the detection rate for stage I BC was 2.6% vs 90.9% for stage IV, underscoring the challenge of detecting early-stage BC via ctDNA ...

8. aacrjournals.org aacrjournals.org/clincancerres/article/31/11/2173/762522/Detection-of-Circulating-Tumor-DNA-Using-a-Tissue

Detection of Circulating Tumor DNA Using a Tissue-Free ... For MRD tests in breast cancer including all subtypes, reported sensitivities for recurrence range from 80% to 89% with greater than 95% specificity (7, 23–27).

9. sciencedirect.com sciencedirect.com/science/article/pii/S2468294222001009

Circulating tumor DNA for breast cancer: Review of active ... Circulating tumor DNA has been used to detect tumor burden and minimal residual disease in metastatic breast cancer. •. There are multiple uses of ctDNA that ...