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

NCT05333874 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 042110Pro2022000044
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 12

Brief 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. 1.Understand ctNDA kinetics in the neoadjuvant and adjuvant setting
2. 2.To identify any associations between clinical staging and measurable ctDNA

Conditions

Breast Cancer, Early-Onset

Keywords

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Detectable Circulating tumor DNA ctDNA

  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.

  Five Years

Secondary Outcomes (1)

• Levels of Detectable Circulating tumor DNA ctDNA

  Five Years

Study Arms (2)

Neoadjuvant chemotherapy

ACTIVE COMPARATOR

If Circulating tumor DNA (ctDNA) blood test is positive, change in treatment can be made. Participants will be monitored with ctDNA at 60days, 3 months, 6 months, 9 months, 12 months, 18months and 24months from surgery. The participant's core biopsy specimens will be sent to NateraTM to sequence the primary tumor. The baseline blood work for ctDNA will be collected prior to the initiation of systemic therapy. Subsequently, ctDNA will be collected prior to each cycle of neoadjuvant chemotherapy. Participants will undergo surgery and ctDNA needs to be collected fourteen days post-surgery The treating oncologist will complete a questionnaire to determine how ctDNA impacts treatment decisions in the adjuvant setting once the results from the fourteen day ctDNA is available and at the time of ctDNA re-emergence. Participants will complete participant questionnaire at 3 months, 6months, 12months and 24 months post-operatively.

Drug: Neoadjuvant chemotherapy administered before surgical extraction of a tumor

Observational

OTHER

Observation for triple negative breast cancer (TNBC): No adjuvant chemotherapy. Patients may complete checkpoint inhibitor from neoadjuvant setting. human epidermal growth factor receptor 2 (HER2) positive breast cancer: complete twelve months of anti-HER2 therapy, which was initiated in neoadjuvant setting), participants in the observation arm, will be monitored for Circulating tumor DNA (ct-DNA) re-emergence and systemic therapy can be added at the time of ctDNA re-emergence.

Other: Observational

Interventions

Observational OTHER

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.

Also known as: No adjuvant chemotherapy

Observational

Neoadjuvant chemotherapy administered before surgical extraction of a tumor DRUG

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.

Also known as: Neoadjuvant chemotherapy

Neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (12)

Trinitas Hospital and Comprehensive Cancer Center

Elizabeth, New Jersey, 07202, United States

Location

RWJBarnabas Health - Robert Wood Johnson University Hospital

Hamilton, New Jersey, 08690, United States

Location

Jersey City Medical Center

Jersey City, New Jersey, 07302, United States

Location

Monmouth Medical Center - Southern Campus

Lakewood, New Jersey, 08701, United States

Location

Cooperman Barnabas Medical Center

Livingston, New Jersey, 07052, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Robert Wood Johnson Barnabas Hospital -Somerset

Somerville, New Jersey, 08876, United States

Location

Steeplechase Cancer Center

Somerville, New Jersey, 08876, United States

Location

Monmouth Medical Center Vantage Point Infusion Cente

West Long Branch, New Jersey, 07746, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Neoadjuvant Therapy; Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Mridula George, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: A pilot study to evaluating the role of ctDNA in patients with Stage II-III triple negative breast cancer and HER2 positive breast cancer. Participants who have ctDNA post neoadjuvant therapy and surgery will be initiated on adjuvant systemic therapy per treating physician's choice. ctDNA will be monitored up to 24 months to study ctDNA kinetics. 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.

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: April 6, 2022
• Primary Completion (Estimated): November 28, 2027
• Study Completion (Estimated): November 28, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)