Status:
ACTIVE_NOT_RECRUITING
CIPHER Study: Pilot Study to Study the Role of ctDNA in Triple Negative and HER2 Positive Early Stage
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Breast Cancer, Early-Onset
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 ...
Detailed Description
To determine whether early detection of Circulating tumor DNA (ctDNA) after neoadjuvant systemic therapy help tailor adjuvant therapy and reduce risk of relapse in patients who are at increased risk o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2027
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05333874
Start Date
April 6 2022
End Date
November 28 2027
Last Update
November 15 2023
Active Locations (12)
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1
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07202
2
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, United States, 08690
3
Jersey City Medical Center
Jersey City, New Jersey, United States, 07302
4
Monmouth Medical Center - Southern Campus
Lakewood, New Jersey, United States, 08701