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

Prior treatment

• Any other concurrent malignancy
• 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

Other illness

• Evidence of metastatic breast cancer
• 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
• History of psychiatric illness or social situations that would limit compliance with study requirements

Lab values

• 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

Other

• Participant is pregnant

• 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