MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

Description

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.

Conditions

Breast Cancer

Study Overview

Study Details

Study 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.

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

MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

CHS Grandview, Birmingham, Alabama, United States, 35243

Anchorage

Providence Alaska Medical Center, Anchorage, Alaska, United States, 99508

Phoenix

Arizona Oncology Associates, PC, Phoenix, Arizona, United States, 85006

Tucson

Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States, 85704

Bakersfield

Adventist Health - Bakersfield, Bakersfield, California, United States, 93301

Palm Springs

Comprehensive Cancer Center at Desert Regional Medical Center, Palm Springs, California, United States, 92262

Redding

North Valley Breast Clinic, Redding, California, United States, 96001

San Francisco

UCSF Breast Care Center, San Francisco, California, United States, 94158

Van Nuys

Valley Breast Care, Van Nuys, California, United States, 91405

Aurora

Rocky Mountain Cancer Centers, Aurora, Colorado, United States, 80012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Agendia,

William Audeh, MD, STUDY_DIRECTOR, Agendia, Inc.

Joyce O'Shaughnessy, MD, PRINCIPAL_INVESTIGATOR, Texas Oncology - Baylor Charles A. Sammons Center

Study Record Dates

2037-12