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

Running, not enrolling · Early Phase 1

Conditions studied: Breast Cancer, Early-Onset

In brief

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

Key facts

Study ID

NCT05333874

Run by

Rutgers, The State University of New Jersey

People needed

34

Starts

2022-04-06

Expected to finish

2027-11-28

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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