RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: FLEX: Liquid Biopsy for Breast Cancer, a Pilot Study

Status

Open

Description

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.

Objective

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.

Treatment

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):

Conditions

Breast

Phases

II

Therapies

Drugs

Age Group

Adult

Main Investiagtor

Crozier, Jennifer

Practice

Breast

Scope

National

Participating Institutions

Baptist MD Anderson Cancer Center

Eligibility

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

Nct ID Number

Secondary Trial ID Number

FLEX Liquid Biopsy

Keywords

Observational

More Information

clinicaltrials.gov

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