Unlike other tumor types, breast cancer – particularly HR+ breast cancer – must be monitored over a long period of time. Recent studies* have shown that the risk relapse for HR+ breast cancer is higher in years 5-20 post-diagnosis compared to the first 5 years. It is now apparent that traditional clinical and pathologic tools are insufficient to determine high risk of late recurrence.
RaDaR is a ctDNA-based MRD test with applicability in different subtypes of breast cancer and different timepoints.
A growing body of evidence confirms that MRD testing offers significant advantages over traditional monitoring methods and can help detect early signs of disease progression.
In some cases, MRD testing is able to detect recurrence more than a year before it is detectable on imaging, allowing potential intervention while the disease burden is still low and treatable.
RaDaR applicability in breast cancer
- Risk stratification: How likely is it for your patient’s tumor to recur? A positive ctDNA result can mean a high risk of recurrence.
- Recurrence surveillance: Regular monitoring with ctDNA may indicate tumor recurrence, often before imaging results.
Clinical support for ctDNA surveillance in breast cancer
RISK STRATIFICATION DURING NEOADJUVANT THERAPY IN EARLY-STAGE BREAST CANCER
Early-stage breast cancer patients are routinely treated with neoadjuvant chemotherapy. For these patients, achieving a pathologic complete response (pCR) is strongly associated with good outcomes.
TRACER is an ongoing study utilizing RaDaR in early breast cancer as an additive test to monitor patient response to therapy with continued surveillance, to predict early metastatic recurrence. Preliminary results from the study suggest that in ER+ breast cancer patients, failure to achieve a pathologic complete response, measured by clearance of ctDNA by RaDaR, by cycle 2 or 3 of neoadjuvant treatment, is associated with an increased risk of disease recurrence.1
Two graphs showing recurrence rates vs. early ctDNA clearance, as measured by RaDaR. The first graph shows the difference in probability of distant metastasis-free survival (DMFA) between subjects who tested ctDNA negative at cycle 2 or 3 of therapy vs. subjects who tested ctDNA positive at the same timepoint. Ten subjects were ctDNA negative and 15 were ctDNA positive at baseline. The hazard ratio for ctDNA negative vs. ctDNA positive was 0.1766 (95% CI: 0.02988-1.043). The second graph shows probability of recurrence-free survival (RFS) in the same treatment group. The hazard ratio for ctDNA negative vs. ctDNA positive was 0.3648 (95% CI: 0.07148-1.862).
RISK ASSESSMENT WITH RESIDUAL DISEASE AFTER SURGERY IN EARLY-STAGE BREAST CANCER
In early-stage breast cancer patients, pathologic complete response (pCR) is used to assess a breast cancer patient’s risk of recurrence post-surgery.
In 2021, Cutts R, et al. assessed the ability of RaDaR to assess residual disease after surgery in early-stage breast cancer patients of multiple subtypes.2 The study found that patients with ctDNA detected by RaDaR after surgery were nearly 7 times more likely to experience disease recurrence than patients who were ctDNA-negative.
In the same study, RaDaR was utilized to monitor patients over time. RaDaR detected recurrent disease with a median of 8.88 months ahead of imaging. This included all patients experiencing a brain metastasis.
Graph showing disease-free survival rates of subjects who tested ctDNA negative vs. subjects who tested ctDNA positive over time (months since surgery), as measured by RaDaR. The hazard ratio for ctDNA negative vs. ctDNA positive was 6.863 (95% CI: 2.45-19.2).
RECURRENCE SURVEILLANCE IN EARLY-STAGE BREAST CANCER
In patients with HR+/HER2- early-stage breast cancer, the risk of recurrence remains steady for decades; in fact, most distant recurrences occur >5 years after initial diagnosis. Current screening tools are limited to symptoms or radiographic evidence of macroscopic disease.
In 2022, Lipsyc-Sharf M, et al. studied 83 patients with stage II or III HR+/HER2- breast cancer diagnosed at least 5 years prior.3 Patients were serially tested every 6 to 12 months with RaDaR, and followed by standard of care clinical guidelines. RaDaR identified MRD prior to all cases of distant metastatic recurrence with a median lead time of 12.4 months.
Graph showing an improved recurrence-free survival rate for subjects who tested ctDNA negative vs. subjects who tested ctDNA positive over time (months since surgery), as measured by RaDaR.
RaDaR has been carefully designed to help you detect tumor DNA in the blood with exceptional sensitivity and specificity
- Increased accuracy with a tumor-informed, personalized panel design: RaDaR sequencing assays monitor up to 48 tumor-specific mutations, unique to each patient’s tumor, to help detect circulating tumor DNA (ctDNA)
- Earlier detection with high sensitivity: RaDaR can detect extremely low levels of ctDNA in the blood, with a demonstrated LoD95 = 0.001% VAF. This can give additional time for important treatment management decisions
- Fewer false positives with high specificity: RaDaR has a demonstrated analytical specificity of 100% in validation studies, giving you the confidence that comes from having more reliable results
NeoGenomics has been supporting oncologists and pathologists in their goal to provide patients with the best care possible since 2002.
LoD95 = limit of detection, working at a confidence of 95%; VAF = variant allele fraction.
How to order a RaDaR test
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PAPER ORDER FORMS
Complete a RaDaR test requisition form.
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