Clinical Trial ID: NCT03053193
FLEX: Liquid Biopsy for Breast Cancer, a Pilot Study
Patients being evaluated for risk of recurrence and possible neoadjuvant therapy will be enrolled in this FLEX substudy. Participating patients will consent to have serial blood drawn and evaluated in addition to, and in conjunction with, standard of care tumor tissue biopsy.
This study aims to identify circulating analytes within blood that are prognostic indicators of tumor burden, treatment response, and survival in patients with early stage breast cancer. Another aim will be to assess the possibility of expanding the clinical utility of both MammaPrint and BluePrint in liquid biopsy diagnostics.
Chemotherapy, targeted therapy, and endocrine therapy is according to NCCN guidelines or other peer reviewed established regimens. Specific regimens are at the discretion of the treating physician. MammaPrint Low Risk (Reference Arm): MammaPrint High Risk (Study Arm):
Baptist MD Anderson Cancer Center
7.1 Inclusion Criteria Primary enrollment into the FLEX Registry Secondary informed consent form signed on the same day or before enrollment Have histologically confirmed, stage II/III breast cancer Candidate for neoadjuvant systemic therapy as determined by the treating physician Minimum invasive tumor burden greater than or equal to 2.5cm as confirmed by diagnostic imaging 7.2 Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria Failure to obtain a baseline blood draw for this protocol Metastatic disease at the time of diagnosis (stage IV disease) Recurrent disease, other malignant tumor (with the exception of non-melanomic skin cancer), or previously treated History of malignancy Stage 0 (in situ) disease Pregnancy Serious comorbidities, such as serious heart, lung, liver diseases, poor cardiac function
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FLEX Liquid Biopsy