Breast Cancer
FLEX Registry: MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Study)
Description
The FLEX Study will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I, II, or III breast cancer who receive MammaPrint®, with or without BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Study. which is intended to enable additional study sub-groups at low incremental effort and cost, will utilize an adaptive design, where additional targeted sub-studies and sub-groups can be added after the initial study is opened. Patients who were enrolled in an initial study sub-group of FLEX will also be eligible for inclusion in additional study sub-groups if they meet all criteria. Additional study sub-groups and sub-studies may be investigator-initiated, and will be added as appendices to the protocol of the initial, or baseline, study. Clinical data
supporting the additional study sub-groups and sub-studies that a patient is eligible for can be collected, as specified in appendices to the baseline protocol.
Inclusion Notes
For a full description of this trial, please go to the listing on www.clinicaltrials.gov
Eligibility Criteria
Inclusion Criteria
Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing as standard of care (male or female)
Informed consent form signed on the same day or before enrollment
New primary lesion
Patients 18 years of age or older
Exclusion Criteria:
Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria, or insufficient material to obtain full genome data
Metastatic disease
Recurrent disease
Stage 0 disease
Start Date
Monday, February 26, 2024
Principal / Contact Name
Catherine Ronaghan, MD