Quantum Leap Logo with a gradient

Natera to Present Data from the BEATRICE and I-SPY2 Trials in Early-Stage TNBC and HR+/HER2- Breast Cancer at the 2022 AACR Annual Meeting

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it will present new data relating to its personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, at the annual meeting of the American Association for Cancer Research taking place April 8 – 13, 2022.

Signatera ctDNA dynamics are both predictive and prognostic in neoadjuvant TNBC. Lead time up to 30 months between Signatera positivity and radiographic recurrence.

AUSTIN, Texas, April 11, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it will present new data relating to its personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, at the annual meeting of the American Association for Cancer Research taking place April 8 – 13, 2022.

Natera will have two data presentations in early-stage breast cancer, focused on patients that are high-risk hormone receptor-positive/HER2-negative (HR+/HER2-) and/or with triple negative breast cancer (TNBC). These data are the latest in a fast-growing body of evidence supporting the clinical use of Signatera MRD in breast cancer across all major subtypes.

Details about the presentations are as follows:

Abstract # 2796 | Poster Presentation | Date/time: Tuesday April 12, 9am-12:30pm

Circulating Tumor DNA Prognosis in Adjuvant Triple Negative Breast Cancer

Tumor tissue and longitudinal plasma samples were collected post-surgery from 186 TNBC patients enrolled in the phase 3 BEATRICE clinical trial (NCT00528567) and analyzed using a research-use-only version of Natera’s personalized ctDNA technology. The results demonstrate that ctDNA status in samples collected post-surgery provided independent prognostic value beyond the known risk factors of lymph node involvement, tumor size and presence of tumor infiltrating lymphocytes.

  • 19.9% of patients with early-stage TNBC were found to have detectable ctDNA after surgery, which was strongly associated with inferior outcomes (IDFS and OS)
  • Lead time between first ctDNA positivity and radiographic recurrence was 6.1 months at the median, ranging up to 30.5 months

“TNBC is the most aggressive type of breast cancer, with a major unmet need for better diagnostic tools to identify high risk patients and inform cancer management,” said Angel Rodriguez, M.D., medical director of oncology at Natera. “This study builds upon the prior scientific literature, further validating Signatera as a strong prognostic factor in TNBC, with significant potential to improve patient care.”

Abstract # 7878 | Poster Presentation | Date/time: Tuesday April 12, 9am-12:30pm

Comparison of the Predictive and Prognostic Significance of Circulating Tumor DNA in Patients with High-Risk HER2-Negative Breast Cancer Receiving Neoadjuvant Chemotherapy

This study analyzed 734 blood samples collected serially during neoadjuvant chemotherapy (NAC) from 106 HR+/HER2- and 97 TNBC patients enrolled in the I-SPY2 trial, one of the largest trials in the neoadjuvant setting.

  • In TNBC, early clearance of ctDNA after just three weeks of treatment was a significant predictor of pathologic complete response
  • Patients who were ctDNA-negative after NAC, in both subtypes, showed significantly improved distant recurrence-free survival, even among those patients who did not achieve pathologic complete response

“This data shows the potential utility of personalized ctDNA monitoring with Signatera during neoadjuvant treatment, giving us the ability to, in conjunction with MR imaging, improve the prediction of response early in the course of treatment,” said Laura Esserman, M.D., M.B.A., and Laura van ‘t Veer, Ph.D., breast cancer specialists on the I-SPY2 Trial. “We are integrating this technology into the I-SPY Trial and prospectively testing it to help improve patient care in breast cancer.”

More information on Signatera in breast cancer is available here.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.

About Natera

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visitwww.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., pr@natera.com

SOURCE Natera, Inc.

Related Links

http://www.quantumleaphealth.org

For more information, email karyn.digiorgio@quantumleaphealth.org

Your financial support of any amount can
help make a huge leap in our efforts to
deliver personalized medicine for all.

Donate Here
© Quantum Leap Healthcare Collaborative. 2023-2024.

For Patients

For Investigators

Partnerships

About us

Trials
Resources
Contact Us

For Patients

For Investigators

Partnerships

About us

Studies
Collaborations
Publications
Contact Us
Donate
Investigators Portal

For Patients

For Investigators

Partnerships

About us

Partnerships
One Source
Donate

For Patients

For Investigators

Partnerships

About us

Our Approach
QLHC in the News
Working at QLHC
Contact Us
Donate

Tracey Heather

Advocate Liaison

As Patient Engagement Lead at Quantum Leap, I manage follow-up data projects for the I-SPY 2 Trial, develop strategies to strengthen patient engagement, and oversee the I-SPY Advocate group. After six successful years raising funds to support Quantum’s mission, I embraced this new role last summer, drawn by the opportunity to make a direct impact on the patients we serve. Each day brings new challenges and insights, and I especially enjoy supporting and collaborating with our inspiring I-SPY Advocates.

Outside of work, I am pursuing a Master of Public Administration with a focus on nonprofit management at SF State. I’m passionate about trail running, skiing, live music, camping, traveling, and collegiate gymnastics—my daughter competes at Oregon State. For the past 5 years, I have volunteered with SF CASA as a mentor to an incredible 18-year-old foster youth whose resilience continually reminds me of life’s true priorities.

Carolyn Clark Beedle

Carolyn Clark Beedle, a 2023 breast cancer survivor, joined the advocate program after successful completion of treatment with the UCSF Breast Oncology Program. Her experience working with a patient advocate during her TNBC treatment led to an understanding that empowering women to advocate for their own health and healthcare will contribute to improved health outcomes and broader access to care. Carolyn began advocating for cancer patients and their families during her treatment, now is a member of the Breast Science Advocacy Core (BSAC) with the UCSF Breast Oncology Program, and currently shares information and research with CFNP associates at La Clinica in the Bay Area to inform and empower their patient population.

Carolyn is continuing her on the ground training as an advocate reviewer with both Quantum Health and BSAC and is enrolled in the Patient Advocacy Training in Health Science course with Stanford Medicine. Her 30+ career in corporate marketing/communications, program development and non-profit leadership augmented by her breast cancer treatment experience serves Carolyn well in representing and communicating the patient voice and perspective.

She received her BA (History/English Lit) and MA (Public History/Research and Record Management) from the University of San Diego, is a proud fifth generation San Franciscan, and active board member with numerous non-profits that support social work and the arts.

Silver Alkhafaji

Silver Alkhafaji is a PhD candidate in the Pharmaceutical Sciences and Pharmacogenomics (PSPG) program at UCSF. She received her Bachelor of Science in Chemical Biology from UC Berkeley. Prior to UCSF, she worked in the Clinical Pharmacology Department at Genentech. Silver’s current research focuses on non-invasive liquid biopsies to predict response and side effects of immunotherapies and endocrine therapies in early-stage breast cancer participants in I-SPY 2.

Silver is interested in clinical outcomes research to advance precision medicine and improve cancer patients’ quality of life. She is passionate about health equity, inclusive research, patient advocacy, and women’s health.
Silver volunteers at the Patient and Family Cancer Support Center at UCSF where she assists in patient navigation and connecting patients and their families with resources that improve their healthcare experience while receiving cancer treatments and/or during survivorship. 

Through her DEI work in her PhD program, Silver raises awareness around issues related to social justice and community building through organizing community-centered events. Additionally, she is a member of the Life Sciences Career Advisory Council at Thrive Scholars, where she enjoys supporting college students of color from economically disadvantaged communities in providing the opportunities they need to thrive at top colleges and in high-trajectory careers. 

Silver is a member of the American Association of University Women (AAUW) Alameda Branch where she focuses her efforts on increasing membership of community college women coming from exceptional backgrounds: student parents, low-income, and first-generation college students.

In her free time, she writes poetry and prose on emotional healing, radical acceptance, and patience. Writing has helped her process difficult situations and connect with people on a deeper level.

Jane Mortimer

Jane is a breast cancer survivor and advocate dedicated to positively impacting the lives of women affected by the disease. Diagnosed with triple negative breast cancer in 2012, she participated in the I-SPY 2 trial at UCSF and has been cancer free for more than ten years.

Her advocacy journey began in 2003 at UCSF as a volunteer with the Patient and Family Cancer Support Center and Decision Support Services and she previously managed the Peer Support program at UCSF. Drawing on her experience in marketing and media strategy, she uses her skills to make a meaningful impact by supporting advocacy and research that improves outcomes for women living with breast cancer.

Jan Tomlinson

In March of 2023 , Jan was diagnosed with a large aggressive triple negative breast cancer and informed that her cancer was the” bad girl” of cancer and offered standard chemotherapy for 24 weeks. Devasted by the diagnosis Jan felt like she had a dire prognosis. After seeking several opinions, she opted to join a Clinical Trial program for her treatment. The trial consisted of significantly less chemotherapy, and monitored closely over a 12-week period, The data predicted a complete pathological response , and she then went immediately to surgery. Pathology reports supported that she had a successful outcome reaching PCR meaning the tumor was gone, and no residual cancer was found in the surrounding tissue or lymph nodes. Jan was thrilled when her surgeon advised her of the results. The experience made Jan want to give back and share information that she received when she was at a critical juncture in her diagnosis. She is so passionate about making sure that everyone knows that the standard of care is one treatment option.

As she says, “ clinical trials have to be on the table” Because she achieved PCR, she expects a great outcome. She wants to share her story and encourage other women to strongly consider and participate in clinical trials. Jan is a UCSF Patient Advocate, involved in several programs they lead. Jan also is a BLACC Cab Member. Jan recently was in Washington DC to participate on a panel on Clinical Trials for ISPY at the National Press Club. UCSF will be hosting the RISE Up For Breast Cancer event where Jan will share her experience with clinical trials.

Deborah Collyar

Deb is a connector who founded Patient Advocates in Research (PAIR) “where research meets reality,” bringing ideas and people together for medical advances that offer real results for diverse patients and families.

Her vast experience between the worlds of tech, communication, strategy, management, policy, and equity bridges gaps between patients, scientists, medical providers, payers, governments, and non-profits.

Deb infuses patient engagement into projects, gathers relevant patient input, and encompasses many diseases, programs and policies at grassroots, national and international levels through companies, academia, and governments.

Key patient insights are delivered throughout discovery, development, clinical trials, results reporting, data-sharing, standards, genomics, and into practice.

Her experience spans translational and clinical research, epidemiology, health outcomes, and health delivery research with academia, federal agencies, companies, and patient communities.