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CIPHER Study: Pilot Study to Study the Role of ctDNA in Triple Negative and HER2 Positive Early Stage
Sponsor: Rutgers, The State University of New Jersey
Summary
Primary Objective: 1\) To examine the impact of Circulating tumor DNA (ctDNA) (expressed as mean tumor molecules per ml) on treatment decision making in patients with early stage breast cancer after neoadjuvant therapy and surgery Secondary Objectives: 1. Understand ctNDA kinetics in the neoadjuvant and adjuvant setting 2. To identify any associations between clinical staging and measurable ctDNA
Official title: CIPHER Study: Pilot Study to Study the Role of ctDNA in Triple Negative and HER2 Positive Early Stage Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2022-04-06
Completion Date
2027-11-28
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Neoadjuvant chemotherapy administered before surgical extraction of a tumor
SignateraTM 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 Signatera methodology 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 tissue. This maximizes accuracy for detecting the presence or absence of 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 quantify how much cancer is left in the body, to improve prognosis and help optimize treatment decisions, based on the tissue-informed testing of mutations.
Observational
In participants, undetectable ctDNA at fourteen days will be in the observation arm (observation defined as TNBC: No adjuvant chemotherapy. Participants may complete checkpoint inhibitor from neoadjuvant setting; HER2 positive BC: Completed one year of anti-HER2 therapy from the neoadjuvant setting). No investigational drugs will be used. Samples of ctDNA will be collected at time points described in the study arm.
Locations (12)
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, United States
Jersey City Medical Center
Jersey City, New Jersey, United States
Monmouth Medical Center - Southern Campus
Lakewood, New Jersey, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Robert Wood Johnson Barnabas Hospital -Somerset
Somerville, New Jersey, United States
Steeplechase Cancer Center
Somerville, New Jersey, United States
Monmouth Medical Center Vantage Point Infusion Cente
West Long Branch, New Jersey, United States