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ACTIVE NOT RECRUITING
NCT05333874
EARLY_PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

OTHER

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