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What Academic Breast Oncologists Are Discussing About ctDNA in Clinical Decision-Making

Circulating tumor DNA (ctDNA) molecular residual disease (MRD) testing is rapidly becoming an essential tool in personalized surveillance strategies across early-stage and advanced breast cancer.

In this clinical roundtable monograph published in Clinical Advances in Hematology & Oncology, leading academic breast oncologists evaluate emerging real-world evidence and clinical utility data for Signatera™—a bespoke, tumor-informed ctDNA assay[1].

Key Discussion Highlights:

  1. Management of Imaging-Negative, ctDNA-Positive Patients: How early molecular detection provides a median lead time of 13.5 months ahead of radiographic recurrence[2], allowing oncologists to tailor surveillance intensity and evaluate treatment intervention strategies before overt clinical relapse occurs[1].
  2. Refining Recurrence Risk Beyond Pathologic Response: Evaluating ctDNA dynamics post-neoadjuvant therapy to identify residual disease burden that standard pathologic complete response (pCR) assessment may miss[3].
  3. Personalizing Care in Special Populations: Examining the role of serial ctDNA testing in elderly or frail patients to enable precise risk stratification and balance treatment benefit with quality of life[4].

With ~100% sensitivity and specificity across all breast cancer subtypes[2] and >99% negative predictive value (NPV) in serial testing[5], Signatera™ stands as the only ctDNA MRD assay clinically validated as a predictive biomarker for both disease-free survival (DFS) and overall survival (OS)[6, 7, 8].

References:

  1. Mouabbi, J. A., et al. (2026). Molecular residual disease (MRD) testing: Advancing clinical decision-making in breast cancer. Clin Adv Hematol Oncol, 24(4, Suppl 4), 1–15.
  2. McHayleh, W., et al. (2025). Clinical performance of Signatera Genome assay for predicting recurrence in patients with breast cancer. SABCS 2025, Abstract PS2-07-26.
  3. Magbanua, M. J. M., et al. (2025). Circulating tumor DNA refines risk stratification of neoadjuvant therapy-resistant breast tumors. Nat Commun, 16(1), 9945.
  4. Carleton, N., et al. (2026). Use of ctDNA in older women with ER+ breast cancer to facilitate surgical de-escalation. Clin Cancer Res.
  5. Pusztai, L., et al. (2025). Circulating tumor (ct) DNA monitoring of ER+/HER2- high-risk breast cancer during adjuvant endocrine therapy. ASCO 2025, Abstract 1010.
  6. Powles, T., et al. (2025). Clinical utility of circulating tumor DNA in solid tumors. N Engl J Med, 392(8), 710–722.
  7. Kotani, D., et al. (2023). Molecular residual disease and efficacy of adjuvant chemotherapy in patients with solid tumors. Nat Med, 29(1), 127–134.
  8. Nakamura, Y., et al. (2024). Circulating tumor DNA analysis guiding adjuvant therapy in solid tumors. Nat Med, 30(3), 812–820.
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