The Importance of ctDNA in Breast Cancer Diagnosis and Treatment Planning Mridula George MD

Dr. Mridula George The Importance of ctDNA in Breast Cancer Diagnosis and Treatment Planning


The Importance of ctDNA in Breast Cancer Diagnosis and Treatment Planning Mridula George MD

By Mridula George, MD

Breast cancer (e.g., metastatic breast cancer) is the most common cancer in women worldwide, and early detection and personalized treatment are crucial for improving patient outcomes. Recently, the use of circulating tumor DNA (ctDNA) has emerged as a promising tool for the diagnosis and treatment of breast cancer.

Initially, ctDNA (circulating tumor DNA) was mainly used in the metastatic setting, where it helped clinicians monitor disease progression and identify the most effective treatments. However, with the development of more sensitive assays, ctDNA can now also be used in the neoadjuvant and adjuvant settings. Several ongoing clinical trials are investigating the use of ctDNA in these settings, with the goal of improving patient outcomes.


What are the advantages of ctDNA Testing?

One of the most significant advantages of ctDNA (circulating tumor DNA) is its ability to detect minimal residual disease (MRD), which is the presence of small amounts of cancer cells that remain after treatment. Detecting MRD is crucial because it indicates that the patient is at an increased risk of recurrence. By monitoring ctDNA levels, clinicians can identify patients who are at risk of recurrence and initiate treatment earlier, potentially improving their outcomes.

Additionally, ctDNA can provide valuable information about the genetic profile of the tumor, which can guide treatment decisions. For example, if a patient's ctDNA levels are rising while on a particular treatment, it is an indication that the treatment is no longer effective, and a change in treatment may be necessary.


What can the clinical trials at Rutgers Cancer Institute tell us?

The Rutgers Cancer Institute is conducting an ongoing study to assess the use of ctDNA in patients with stage 2 and stage 3 breast cancer. The study involves screening patients for ctDNA and monitoring them during neoadjuvant treatment and post-surgery in the adjuvant setting. This study aims to provide valuable insights into how ctDNA (circulating tumor DNA) can help clinicians make more informed treatment decisions.

In conclusion, ctDNA has significantly changed the way breast cancer is diagnosed and treated. It is a powerful tool for detecting MRD, identifying patients at risk of recurrence, and guiding treatment decisions. Ongoing studies (e.g. prospective studies, meta analysis, gene expression, clinical trail phase 1, phase 2, phase 3 or FDA approval), such as the one conducted by the Rutgers Cancer Institute, will help us better understand the potential of ctDNA in improving breast cancer patient outcomes.


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What is the role of ctDNA Testing in Breast Cancer Diagnosis and Personalized Treatment

ctDNA testing for breast cancer has emerged as a valuable tool for doctors in diagnosis and personalized treatment. It helps to detect and quantify small amounts of tumor-derived DNA fragments circulating in the bloodstream, and these fragments are providing valuable information about the molecular profile of the tumor.

One of the significant advantages of ctDNA testing is its ability to help diagnose breast cancer at an early stage. The presence of ctDNA in the bloodstream can indicate the presence of cancer cells, even before imaging tests or other clinical symptoms become evident. By detecting ctDNA (circulating tumor DNA) early, doctors can diagnose breast cancer before it has a chance to spread, leading to better treatment outcomes and increased survival rates.

ctDNA testing also helps with personalized treatment decisions by identifying the specific mutations (e.g. somatic mutations, gene mutations, EGFR mutations) present in a patient's tumor. This information can guide doctors in selecting the most appropriate treatment options, including chemotherapy, targeted therapy, and immunotherapy. In addition, ctDNA (circulating tumor DNA) testing can help monitor treatment response and detect minimal residual disease (MRD), allowing doctors to adjust treatment plans to improve outcomes.

Furthermore, ctDNA testing is useful in predicting the risk of disease recurrence. Studies have shown that patients with detectable ctDNA after surgery have a higher risk of recurrence, indicating the need for additional treatment or closer monitoring. By detecting MRD, ctDNA testing can identify patients who may benefit from more intensive therapies or closer follow-up to prevent disease recurrence.

In summary, ctDNA testing for breast cancer offers valuable insights into the molecular characteristics of tumors, aiding in diagnosis, treatment selection, monitoring, and predicting disease recurrence. As research continues, ctDNA (circulating tumor DNA) testing is expected to play an increasingly significant role in personalized cancer care.


10 Key Takeaways about ctDNA and Natera

  1. Circulating tumor DNA (ctDNA) is a valuable tool for cancer diagnosis, treatment, and monitoring, as it contains genetic mutations specific to the tumor (cells) it originated from.

  2. Natera is a company that offers ctDNA analysis services through their proprietary technology called Signatera.

  3. Signatera is designed to detect ctDNA in blood sample (s) and monitor treatment response and cancer recurrence in patients with solid tumors.

  4. Signatera has shown high sensitivity and specificity in detecting ctDNA in various cancer types, including lung cancer, colorectal cancer, breast cancer, and bladder cancer.

  5. Signatera has also demonstrated clinical utility in detecting ctDNA (circulating tumor DNA) through ctDNA testing (tumor DNA detection), to help predict treatment response and monitoring disease progression in patients with advanced cancer.

  6. Signatera can be used as a complementary tool to standard imaging and biopsy methods (e.g. liquid biopsy or liquid biopsy and other procedures), providing additional information about tumor burden and treatment efficacy.

  7. Natera offers Signatera as a laboratory-developed test (LDT) that is performed in their CLIA-certified and CAP-accredited laboratory.

  8. Signatera can be customized for each patient based on their tumor-specific mutations, allowing for personalized monitoring and treatment planning.

  9. Natera is committed to advancing the field of ctDNA analysis and developing new applications for Signatera in oncology and beyond.

  10. As the field of ctDNA analysis continues to evolve, Natera and Signatera are poised to play a leading role in improving cancer care through personalized and precise monitoring and treatment strategies.


Natera - About the Company

Natera is a biotechnology startup dedicated to enhancing precision medicine using genomic analysis. The company was founded in 2003 in San Carlos, California, and has operations in the United States, Europe, and Asia. The exclusive technology of Natera comprises very sensitive and accurate molecular diagnostic tests for a variety of illnesses, including cancer, reproductive health, and organ transplantation.


The company offers ctDNA analysis services using its Signatera assay, which can detect tiny quantities of tumor DNA in blood sample (s) and monitor treatment response and cancer recurrence in patients with solid tumors.


Natera provides non-invasive prenatal testing (NIPT) and preimplantation genetic testing (PGT) for in vitro fertilization (IVF) embryos as part of its reproductive health services. Donor-derived cell-free DNA (dd-cfDNA) testing, which can detect rejection episodes in organ transplant patients earlier than other approaches, is part of the company's organ transplant portfolio.


Natera is dedicated to developing genomes and precision medicine through continual research and development, strategic alliances, and collaborations with top academic and clinical institutions. The objective of the organization is to enhance patient outcomes and quality of life through tailored and accurate diagnosis, treatment, and monitoring measures.


Mridula George, MD - About The Author, Credentials, and Affiliations

Mridula George, MD, is a medical oncologist and hematologist at Rutgers Cancer Institute in New Brunswick, New Jersey in her clinical practice, where she specializes in the treatment of solid tumors, including breast cancer, lung cancer, and gastrointestinal cancers, as well as hematologic malignancies. Dr. George completed her medical degree at the Government Medical College in Thiruvananthapuram, India, and went on to complete a residency in internal medicine at Saint Peter's University Hospital in New Brunswick. She then completed a fellowship in hematology and oncology at Rutgers Cancer Institute, where she currently serves as an assistant professor of medicine.


Dr. George is dedicated to providing personalized and compassionate care to her patients, using the latest advances in cancer treatment to improve outcomes and quality of life. Her research interests include exploring new targeted therapies and immunotherapies for solid tumors, as well as studying the use of circulating tumor DNA (ctDNA) for treatment monitoring and predicting treatment response because there are no exact sciences. Dr. George is board-certified in internal medicine, hematology, and medical oncology, and is an active member of several professional organizations, including the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH).