CIPHER Study: Pilot Study to Study the Role of ctDNA in Triple Negative and HER2 Positive Early Stage

NCT05333874 · tracked via the Priya Life Science Israel tracker

Sponsor

Rutgers, The State University of New Jersey

Phase

Phase EARLY_PHASE1

Started

2022-04-06

Last updated

2026-02-09

Condition(s) studied

Breast Cancer, Early-Onset

Investigational drug(s) / intervention(s)

Neoadjuvant chemotherapy administered before surgical extraction of a tumorObservational

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.

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Participants with a diagnosis of clinical Stage II-III triple negative and/or HER2 positive breast cancer * Age ≥ 18 years * Estimated life expectancy of at least twelve months * Participant must be eligible for neoadjuvant systemic therapy per treating physician * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Able to provide signed and dated informed consent form * Must have ctDNA at the time of screening to be eligible for the study * Participants enrolled on other systemic therapy trials may be eligible to participate in the study after discussion with principal investigator * Be willing to present for medical exams and blood draws as scheduled per protocol Exclusion Criteria: * Evidence of metastatic breast cancer * Any other concurrent malignancy * Prior malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least one year prior to study entry * Participant is pregnant * Serious concomitant systemic disorder that would compromise the safety of the participant or compromise the participant's ability to complete the study, at the discretion of the investigator * Bone marrow transplant or other organ transplant recipient * History of psychiatric illness or social situations that would limit compliance with study requirements * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Primary outcome measure(s)

Detectable Circulating tumor DNA ctDNA — Five Years
Participants with detectable ctDNA fourteen days post-operatively will have the option to change adjuvant therapy after discussion with primary provider. SignateraTM 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.

Trial sites (12)

Facility	City	Region
Trinitas Hospital and Comprehensive Cancer Center	Elizabeth	New Jersey
RWJBarnabas Health - Robert Wood Johnson University Hospital	Hamilton	New Jersey
Jersey City Medical Center	Jersey City	New Jersey
Monmouth Medical Center - Southern Campus	Lakewood	New Jersey
Cooperman Barnabas Medical Center	Livingston	New Jersey
Monmouth Medical Center	Long Branch	New Jersey
Robert Wood Johnson University Hospital	New Brunswick	New Jersey
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
Newark Beth Israel Medical Center	Newark	New Jersey
Robert Wood Johnson Barnabas Hospital -Somerset	Somerville	New Jersey
Steeplechase Cancer Center	Somerville	New Jersey
Monmouth Medical Center Vantage Point Infusion Cente	West Long Branch	New Jersey

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05333874 on ClinicalTrials.gov ↗ ← All trials in Israel