Clinical trial · Observational
Monitoring Plasma Tumor DNA in Early-Stage Breast Cancer
Plasma Tumor DNA and Pathologic Complete Response in Early-Stage, High-Risk Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done to see if it is possible to use blood samples to predict response to treatment in breast cancer patients receiving preoperative (or neoadjuvant) therapy. Research has shown that most breast cancers release tumor-specific DNA into the blood (that is, DNA that is specific to the tumor cells or cancer). This DNA can be detected in blood testing known as plasma tumor-DNA or "ptDNA." This DNA is separate from that found in the blood and tissue samples which serve as the "instruction book" or "genetic code" for the cells that make-up the human body. The changes in ptDNA before and after treatment, as well as after surgery, may also help investigators to understand more about a patient's risk of cancer returning and long-term outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ptDNA | Other | — | UNRESOLVED |
| Tissue sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Stage II-III breast cancer
- description
- Up to 229 newly diagnosed stage II-III invasive HER2-positive or triple-negative breast cancer patients planning neoadjuvant therapy (NAT) will be enrolled. ptDNA blood samples as well as a representative tumor tissue sample from both the diagnostic and surgical procedure (if available) will be collected.
- interventionNames
- Other: ptDNA
- Other: Tissue sample
Primary outcomes (1)
- measure
- Correlation of absence of plasma tumor DNA (ptDNA) with pathologic complete response (pCR)
- timeFrame
- 6 months
- description
- To estimate the negative predictive value (NPV) of the absence of plasma tumor DNA (ptDNA) Tumor Specific Mutations (TSMs) after neoadjuvant therapy (NAT) for the absence of residual disease as defined by pathologic complete response (pCR) in stage II-III HER2-positive or triple negative breast cancer (TNBC) NPV = True Negative/True Negative + False Negative (probability that the disease is not present when the test is negative)
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed, histologically confirmed invasive breast cancer that is triple negative (estrogen receptor \[ER\], progesterone receptor \[PR\], and HER2-neu negative) or HER2-positive (any ER/PR status) * Unresected, untreated breast cancer that is T2, T3, or T4a-c; any N (nodal status); and M0 (not metastatic) * ECOG Performance Status of 0 or 1 * Planning to receive a neoadjuvant chemotherapy regimen containing a taxane ± an anthracycline for at least 4 cycles. Patients with HER2-positive disease must also be planning to receive HER2-targeted therapy. * Diagnostic tumor material must be available for correlative analyses * Patients must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * No prior treatment for the current breast cancer, though prior use of selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs) for the prevention of breast cancer is acceptable. * Women who are pregnant or nursing are excluded. * No history of another primary malignancy in the last 5 years prior to registration. Patients with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.
References
Publications (1)
- DERIVEDHunter NB, Parsons HA, Cope L, Canzoniero JV, Navarro FCP, El-Refai S, Anampa JD, Sparano JA, Rimawi M, Storniolo AM, Mainor C, Nanda R, DeMichele A, Gupta GP, Stringer-Reasor EJ, Lynce F, Cobain EF, Puhalla S, Jankowitz R, Rexer B, Mayer I, Hwang ES, Blackwell K, El Ayass W, Lee Y, Tweed C, Wilkinson M, Pennisi A, Sun B, Wright P, Gralow JR, Chen R, Boyle SM, Stearns V, Wolff AC, Park BH. The Pathologic Response Evaluation and Detection in Circulating Tumor-DNA Study: Ultrasensitive Circulating Tumor-DNA Assessment of Breast Cancer Minimal Residual Disease. J Clin Oncol. 2026 May 10;44(14):1283-1295. doi: 10.1200/JCO-25-02934. Epub 2026 Mar 10. PMID 41805422