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Search / Trial NCT03053193

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

Launched by AGENDIA · Feb 10, 2017

Trial Information

Current as of May 03, 2025

Recruiting

Keywords

Breast Cancer Stage I Stage Ii Stage Iii

ClinConnect Summary

The FLEX Registry is a clinical trial aimed at studying how specific gene tests, called MammaPrint® and BluePrint, can help doctors understand breast cancer better. This trial is for patients with early to middle-stage breast cancer (stages I to III) who are undergoing testing on their primary tumor. The goal is to collect information that can lead to new insights into breast cancer treatment and improve patient care.

To participate in this trial, patients must be diagnosed with a new breast cancer tumor and agree to take part by signing an informed consent form. Those with metastatic (spread to other parts of the body) or recurrent breast cancer, or those with very early-stage cancer (stage 0), are not eligible. If you join the trial, you can expect to undergo the MammaPrint® and BluePrint tests, which help determine the best treatment options based on your tumor's gene activity. This study is currently recruiting participants, and it aims to make it easier to add new areas of focus as the research progresses.

Gender

ALL

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

About Agendia

Agendia is a leading molecular diagnostics company specializing in personalized medicine for cancer patients. With a strong focus on breast cancer, Agendia develops innovative genomic tests that provide critical insights into tumor biology, enabling oncologists to make informed treatment decisions. The company is committed to advancing cancer research through rigorous clinical trials and collaboration with healthcare professionals, ultimately aiming to improve patient outcomes and quality of life. Agendia's expertise in genomic profiling positions it at the forefront of precision oncology, driving advancements that empower patients and clinicians alike.

Locations

Baltimore, Maryland, United States

New Orleans, Louisiana, United States

Buffalo, New York, United States

Saint Louis, Missouri, United States

Amarillo, Texas, United States

Seattle, Washington, United States

Anchorage, Alaska, United States

Chicago, Illinois, United States

Syracuse, New York, United States

Seattle, Washington, United States

Clearwater, Florida, United States

Elk Grove Village, Illinois, United States

Redding, California, United States

Atlantis, Florida, United States

Palm Springs, California, United States

Lakeland, Florida, United States

Mineola, New York, United States

Decatur, Georgia, United States

Akron, Ohio, United States

Bethlehem, Pennsylvania, United States

Tampa, Florida, United States

Aurora, Colorado, United States

Fort Worth, Texas, United States

Baltimore, Maryland, United States

Portland, Oregon, United States

Jacksonville, Florida, United States

Aurora, Colorado, United States

Columbia, Missouri, United States

Langhorne, Pennsylvania, United States

Thunder Bay, Ontario, Canada

Miami, Florida, United States

Columbia, Maryland, United States

Nashville, Tennessee, United States

Savannah, Georgia, United States

Shreveport, Louisiana, United States

Albany, New York, United States

Lansing, Michigan, United States

Tel Aviv, , Israel

Flower Mound, Texas, United States

Tyler, Texas, United States

Pittsburgh, Pennsylvania, United States

Atlanta, Georgia, United States

Mount Vernon, Washington, United States

Dallas, Texas, United States

Lawton, Oklahoma, United States

Atlanta, Georgia, United States

Houston, Texas, United States

Eugene, Oregon, United States

Grapevine, Texas, United States

Winter Haven, Florida, United States

Bedford, Texas, United States

Portland, Oregon, United States

Rockledge, Florida, United States

Tucson, Arizona, United States

Sugar Land, Texas, United States

Denver, Colorado, United States

Waco, Texas, United States

Germantown, Tennessee, United States

Springfield, Massachusetts, United States

Southfield, Michigan, United States

Milwaukee, Wisconsin, United States

Longview, Texas, United States

Pittsburgh, Pennsylvania, United States

Miami, Florida, United States

Cincinnati, Ohio, United States

Minneapolis, Minnesota, United States

Daytona Beach, Florida, United States

Carrollton, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Dallas, Texas, United States

Birmingham, Alabama, United States

San Francisco, California, United States

Van Nuys, California, United States

Lakewood, Colorado, United States

Vail, Colorado, United States

Waterbury, Connecticut, United States

Newark, Delaware, United States

Atlantis, Florida, United States

Boca Raton, Florida, United States

Jacksonville, Florida, United States

Jacksonville, Florida, United States

Tampa, Florida, United States

Albany, Georgia, United States

Brunswick, Georgia, United States

Tifton, Georgia, United States

Hoffman Estates, Illinois, United States

Oak Lawn, Illinois, United States

Fort Wayne, Indiana, United States

Bethesda, Maryland, United States

Brandywine, Maryland, United States

Clinton, Maryland, United States

Cumberland, Maryland, United States

Frederick, Maryland, United States

Rockville, Maryland, United States

Silver Spring, Maryland, United States

Grosse Pointe Woods, Michigan, United States

Troy, Michigan, United States

Binghamton, New York, United States

Lake Success, New York, United States

Mount Kisco, New York, United States

Nyack, New York, United States

Rochester, New York, United States

Tarrytown, New York, United States

Cincinnati, Ohio, United States

Horsham, Pennsylvania, United States

Sellersville, Pennsylvania, United States

Charleston, South Carolina, United States

Georgetown, South Carolina, United States

Allen, Texas, United States

Corpus Christi, Texas, United States

Dallas, Texas, United States

Denton, Texas, United States

Katy, Texas, United States

League City, Texas, United States

Lubbock, Texas, United States

Mckinney, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

San Antonio, Texas, United States

San Antonio, Texas, United States

San Antonio, Texas, United States

Webster, Texas, United States

Ogden, Utah, United States

Athens, , Greece

Austin, Texas, United States

Broomall, Pennsylvania, United States

Phoenix, Arizona, United States

Bakersfield, California, United States

Portland, Maine, United States

Annapolis, Maryland, United States

Royal Oak, Michigan, United States

New York, New York, United States

Houston, Texas, United States

Brampton, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

William Audeh, MD

Study Director

Agendia, Inc.

Joyce O'Shaughnessy, MD

Principal Investigator

Texas Oncology - Baylor Charles A. Sammons Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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