Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Rita Mukhtar, MDLaura Esserman, MD
Photo of Laura Esserman
Laura Esserman

Description

Summary

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.

Official Title

MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)

Details

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 25,000 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.

Keywords

Breast Cancer stage I stage II stage III Breast Neoplasms MammaPrint, BluePrint, and Full-Genome Testing MammaPrint and BluePrint testing

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
  • Metastatic disease
  • Recurrent disease
  • Stage 0 disease

Locations

  • UCSF Breast Care Center accepting new patients
    San Francisco California 94158 United States
  • Valley Breast Care accepting new patients
    Van Nuys California 91405 United States

Lead Scientists at UCSF

  • Rita Mukhtar, MD
    Associate Professor, Surgery. Authored (or co-authored) 62 research publications.
  • Laura Esserman, MD
    Professor, Surgery. Authored (or co-authored) 369 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Agendia
ID
NCT03053193
Study Type
Observational [Patient Registry]
Last Updated