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Detection of molecular residual disease in breast cancer patients

EXActDNA-003 / NSABP B-64: Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated With Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease

Observational Exact Sciences Corporation · NCT06401421

This study is testing if checking for cancer DNA in blood and tissue samples can help doctors better manage treatment for women with high-risk, early breast cancer starting chemotherapy.

Quick facts

Study typeObservational
Enrollment1800 (estimated)
Ages18 Years and up
SexAll
SponsorExact Sciences Corporation Industry-sponsored
Drugs / interventionschemotherapy
Locations58 sites (Anchorage, Alaska and 57 other locations)
Trial IDNCT06401421 on ClinicalTrials.gov

What this trial studies

The EXActDNA-003 study aims to enroll participants with high-risk, early breast cancer who are about to start chemotherapy. Participants will provide tissue and blood samples for analysis of circulating tumor DNA (ctDNA) to detect molecular residual disease. The study will follow these participants for up to 5.5 years to assess the effectiveness of ctDNA monitoring in this context. This observational study will help understand the role of ctDNA in managing breast cancer treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed invasive breast cancer who are planning to undergo neoadjuvant chemotherapy.

Not a fit: Patients with early-stage breast cancer who do not meet the high-risk criteria or are not planning to undergo chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the monitoring and management of breast cancer treatment, potentially leading to better patient outcomes.

How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring residual disease in various cancers, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. The participant or a legally authorized representative must provide study-specific informed consent prior to study entry.
2. The participant must be ≥ 18 years of age.
3. ECOG performance status 0 or 1.
4. Histologically confirmed invasive carcinoma of the breast.
5. Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
6. Tumor size ≥ 2.1 cm in greatest diameter.
7. Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
8. Clinically node positive or if node negative, any one of the following:

   1. TNBC or HER2+ subtype
   2. HR+/HER2-negative with at least one of the following:

   i. High tumor grade (G3) ii. Ki67 index of 20% or higher iii. High genomic risk (Oncotype DX® (ODX) Breast Recurrence Score of \> 25, MammaPrint® High, etc.)
9. Willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 Tablespoons) of blood for each research blood draw.
10. Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.

Exclusion Criteria:

1. Definitive clinical or radiologic evidence of metastatic disease.
2. Initiated neoadjuvant therapy for current breast cancer diagnosis.
3. Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers.
4. Completed all therapy (including endocrine therapy) \<5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment.
5. Completed all therapy for any previous hematologic malignancy \< 5 years ago.
6. Multicentric or contralateral invasive breast cancers.
7. Known pregnancy at time of enrollment.
8. Prior solid organ transplant.
9. Prior allogeneic hematopoietic stem cell transplant.

Where this trial is running

Anchorage, Alaska and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerctDNA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.