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

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT03053193
Trial Phases:		Protocol IDs:	FLEX Registry (primary) NCI-2018-02995
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Agendia
NCI Full Details:	http://clinicaltrials.gov/show/NCT03053193

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.

Objectives

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.

Treatment Sites in Georgia

Piedmont Cancer Institute - Atlanta
1800 Howell Mill Road
Suite 800
Atlanta, GA 30318
678-298-3238
www.piedmontcancerinstitute.com

Doctors:

Vasily J. Assikis MD

William S. Jonas MD

Eric D. Mininberg MD

Ha N. Tran MD

Rajni Sinha MD

Jay Rhee MD

Samantha Shams MD

Nikita Tushar Amin MD

Piedmont Cancer Institute - Fayetteville
1267 Highway 54 West
Suite 4200
Fayetteville, GA 30214
678-298-3238
www.piedmontcancerinstitute.com

Doctors:

Jonathan C. Bender MD

Trevor M. Feinstein MD

Vipin Ramprasad Lohiya MD

Piedmont Cancer Institute - Newnan
775 Poplar Road
Suite 310
Newnan, GA 30265
678-298-3238
www.piedmontcancerinstitute.com

Doctors:

Vasily J. Assikis MD

Minesh D. Patel MD

Nikita Tushar Amin MD

Piedmont Cancer Institute - Stockbridge
1240 Eagles Landing Parkway
Suite 260
Stockbridge, GA 30281
678-298-3238
www.piedmontcancerinstitute.com

Doctors:

Eric D. Mininberg MD

Ha N. Tran MD

Vipin Ramprasad Lohiya MD

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.