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

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey

Criteria

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