MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MammaPrint, BluePrint, and Full-Genome Testing.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Greece, Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
Overview
The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.
Detailed description
The FLEX Registry will include all patients with stage I-III breast cancer who have received MammaPrint and BluePrint testing in any clinical setting. Study arm appendices will specify treatment arm, inclusion criteria, and number of patients needed. Approximately 30,000 patients from 125+ US based institutions will be enrolled.
Treatment is at the discretion of the physician adhering to NCCN approved regimens of a recognized alternative.
Clinical data will be collected and entered online at the time points listed: patient enrollment, time of treatment, 1 year post-treatment, and 3, 5, and 10 years post diagnosis.
Objectives:
* Create a large scale, population-based registry of full genome expression data and clinical data to investigate new gene associations with prognostic and/or predictive value * Utilize shared registry infrastructure to examine smaller groups of interest * Generate hypotheses for targeted subset analyses and trials based on full genome data
FLEX is an observational (phase IV) study.
Interventions
- Diagnostic test MammaPrint, BluePrint, and Full-Genome Testing
Agendia will run MammaPrint and BluePrint tests using the full genome testing array.
Primary outcome measures
- A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created. [Time frame: 10 years]
- A shared registry infrastructure to examine smaller groups of interest. [Time frame: 10 years]
Secondary outcome measures (1)
- Subset analyses based on full genome data will be created. [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female)
- Informed consent form signed on the same day or before enrollment
- New primary lesion
Exclusion criteria
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
- Metastatic disease
- Recurrent disease
- Stage 0 disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 130 centers
- CHS Grandview — Birmingham
- Providence Alaska Medical Center — Anchorage
- Arizona Oncology Associates, PC — Phoenix
- Arizona Oncology Associates, PC - HOPE — Tucson
- Adventist Health - Bakersfield — Bakersfield
- Comprehensive Cancer Center at Desert Regional Medical Center — Palm Springs
- North Valley Breast Clinic — Redding
- UCSF Breast Care Center — San Francisco
- … and 122 more centers
Canada · 2 centers
Center list to be confirmed — check the primary protocol.
Greece · 1 center
Center list to be confirmed — check the primary protocol.
Israel · 1 center
Center list to be confirmed — check the primary protocol.
Publications
- O'Shaughnessy J, Brufsky AM, Layeequr Rahman R, Osborne CR, Mahtani R, Elkhanany A, Graham CL, Brown E, Gold LP, Johnson N, Giffoni D, Alberty-Oller JJ, Ramaswamy H, Weber R, Chmielewski-Stivers N, Menicucci AR, Audeh W. Prediction of Anthracycline Benefit in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early-Stage Breast Cancer by the MammaPrint 70-Gene Signature f PMID 42341255
- Brufsky AM, Hoskins KF, Conter HJ, Kelemen P, Habibi M, Samian L, Rahman RL, Lee L, Dias EC, Hampton R, Sieling BA, Osborne CR, Brown E, Elayoubi JA, Sharma P, Ramadurai J, Matt-Amaral L, Santillan AA, Davis S, Albaneze P, Ramaswamy H, Chmielewski-Stivers N, Menicucci A, Audeh W, Whitworth P, Johnson N, O'Shaughnessy J. MammaPrint predicts chemotherapy benefit in HR+HER2- early breast cancer: FLEX PMID 40796181
Identifiers
NCT: NCT03053193 · FLEX Registry