Skip navigation

Signatera™
for Breast Cancer

A personalized, tumor-informed test to help monitor breast cancer and inform critical decisions for care.

Inform Decisions for High Risk Patients

Test

Risk-Stratify Patients

Evaluate ctDNA dynamics during neoadjuvant treatment (NAT) to help assess risk of recurrence

4.35x

greater likelihood of recurrence for patients who do not clear ctDNA by 3 weeks into NAT1-3

Know

Detect Recurrence Earlier

Detect recurrence ahead of conventional imaging and biomarker testing2

10.5 months

median lead time over radiographic recurrence (88% sensitivity)2,4

Decide

Assess Treatment Response

Track changes in ctDNA levels to evaluate treatment response3

6 weeks

to understand response to immunotherapy treatment5

Get Started

Detect Recurrence Before Visceral Crisis

Despite significant improvements in care over the past few decades, approximately 30% of stage II-III breast cancer patients will go on to relapse and die from metastatic disease. 10-15% of those recurrences will present clinically with visceral crisis, which limits treatment options.7

Serial Signatera™ Residual Disease Testing after definitive treatment has been shown to detect relapse a median of 10.5 months (range 0-38 months) ahead of scans and traditional monitoring tools, helping to avoid visceral crisis.4

Inform Questions Across Breast Cancer Treatment

alt text

Explore the Peer-Reviewed Data in Breast Cancer

Neoadjuvant Response Monitoring and Risk Stratification

I-SPY 2 Study Schema

I-SPY 2 Studies: Can ctDNA Refine pCR as a Surrogate Endpoint for Survival?

For patients treated with neoadjuvant therapy, achieving a pathologic complete response (pCR) generally denotes a favorable prognosis. However, how can providers risk-stratify patients who have residual disease?

I-SPY 2 ctDNA Objectives

  • Evaluate ctDNA as a biomarker for monitoring response to neoadjuvant therapy1-3
  • Assess prognostic value of ctDNA in stratifying patients for risk of early metastatic recurrence1-3

The I-SPY 2 Platform Master Protocol

RNA Analysis
  • Response to neoadjuvant chemotherapy (NAC) and investigational treatments assessed through ctDNA dynamics at four time points
  • ctDNA derived from plasma was assessed at four time points: pretreatment (T0), 3 weeks after paclitaxel/study drug initiation (T1), between
    paclitaxel/study drug and anthracycline regimens (T2), and prior to surgery (T3).

I-SPY 2 Results

Early ctDNA Clearance is a Predictor of Better Outcomes1-3

Comparison of Negative Predictive Values (NPV)
  • Patients who cleared ctDNA at T1 (3 weeks into neoadjuvant therapy) had a significantly reduced risk of metastatic recurrence and death.1-3

Learn More

pCR and ctDNA status Can Help Risk-Stratify Patients1-3

RNA Analysis

At T3 across subtypes:

  • Patients who achieved a pCR and cleared their ctDNA had the best survival outcomes; those who did not achieve a pCR and were ctDNA positive
    had the worst outcomes.1–3
  • Regardless of pCR status, persistent ctDNA positivity by T3 was associated with shorter DRFS compared to ctDNA negativity.1–3

Learn More

Surveillance Recurrence Monitoring

The EBLIS Study: Can ctDNA Identify Recurrence Before a Clinical Widespread Progression and Visceral
Crisis?

EBLIS ctDNA Objectives

  • Determine whether ctDNA in plasma can detect recurrent disease earlier than traditional methods
  • Determine lead interval between ctDNA detection and clinical metastatic disease

EBLIS Protocol

RNA Analysis

EBLIS Results

pCR and ctDNA status Can Help Risk-Stratify Patients1–3

RNA Analysis

  • 88% sensitivity: Signatera detected ctDNA in 30 out of 34 patients before clinical or radiologic relapse4
  • 10.5 months median lead time over radiographic recurrence (range 0-38 months)4
  • HR+/HER2–: median 13 months4
  • HR–/HER2+: median 15.74
  • HR+/HER2+: median 6 months4
  • TNBC: median 8 months4

Learn More

Advanced/Metastatic Immunotherapy Monitoring

The INSPIRE Study: Can ctDNA be Validated as an Early Biomarker of ICI Treatment Response?

Despite dramatic improvements in cancer care using antibodies that block immune checkpoint proteins, less than 20% of eligible patients will derive sustained response or clinical benefit to immune checkpoint inhibitors (ICIs).7 How can ctDNA accurately identify those patients who are benefiting from ICI treatment?

INSPIRE Objectives

The prospective phase II INSPIRE trial addressed clinically relevant issues related to monitoring response to ICIs by assessing baseline ctDNA status and ctDNA dynamics.

INSPIRE Protocol

RNA Analysis

INSPIRE Results

Signatera™ predicts immunotherapy benefit as early as week 6.5

Baseline ctDNA concentration and ctDNA dynamics during treatment correlated with progression-free survival, overall survival, clinical response, and clinical benefit.5

  • A decrease in ctDNA levels from baseline to the beginning of cycle 3 is a strong predictor of increased OS and PFS.5
  • Clearance of ctDNA at any time point resulted in superior clinical outcomes. All 12 patients who cleared ctDNA for at least one on-treatment time point remained alive during follow-up period (median follow-up beyond first clearance of 25.4 months)5
Comparison of Negative Predictive Values (NPV)

Learn More

Support the Patient Journey

When Rachelle was diagnosed with stage IIB, HR+/HER2- breast cancer at age 29, she was a young entrepreneur determined not to let her diagnosis define her. After she finished definitive treatment, she and her doctor decided to use serial Signatera™ testing to monitor disease for signs of recurrence every three months.

Learn how Signatera™ helped Rachelle gain peace of mind and how she became a dedicated patient advocate along the way.

“The confidence of [getting tested with] Signatera allows me to live my best life every day.” – Rachelle – entrepreneur, advocate, and breast cancer survivor

Partner to Advance Breast Cancer Treatment

TRIAL SPONSOR DESCRIPTION
ZEST GSK Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Either Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease (NCT04915755). Read about this study
DARE Criterium, Inc. DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage IIIII, Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT04567420). Read about this study
LEADER Massachusetts General Hospital CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer (NCT03285412) Read about this study

Is Signatera™ right for your breast cancer patients?



References

1Magbanua MJM, et al. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann Oncol. 2021 Feb;32(2):229-239. https://doi.org/https://doi.org/10.1016/j.annonc.2020.11.007

2Magbanua MJM, et al. Personalized circulating tumor DNA as a predictive biomarker in high-risk early stage breast cancer treated with neoadjuvant chemotherapy with or without pembrolizumab. Cancer Res. 2021 81 (4_Supplement): PD9-02.

3Magbanua MJM, et al. Comparison of the predictive and prognostic significance of circulating tumor DNA in patients with high risk HER2- breast cancer receiving neoadjuvant chemotherapy. Poster presented at: AACR 2022; April 8-13, 2022; New Orleans, LA.

4Shaw JA, et al. Serial postoperative ctDNA monitoring for early detection of breast cancer recurrence. Poster presented at: ASCO; June 3-7, 2022; Chicago, IL.

5Bratman SV, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat Cancer. 2020;1(9):873-881. https://doi.org/10.1038/s43018-020-0096-5

6Coombes RC, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence. Clin Cancer Res. 2019 Jul 15;25(14):4255-4263. https://doi.org/10.1158/1078-0432.CCR-18-3663

7Haslam A, et al. Estimation of the percentage of US patients with cancer who are eligible for immune checkpoint inhibitor drugs. JAMA Netw Open. 2020;3(3):e200423. https://doi.org/10.1001/jamanetworkopen.2020.0423