PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score (PROMIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Agendia
Sponsor:
Information provided by (Responsible Party):
Agendia
ClinicalTrials.gov Identifier:
NCT01617954
First received: June 8, 2012
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

This is a prospective study that will assess the impact of MammaPrint on chemotherapy + endocrine versus endocrine alone treatment decisions in patients with an Oncotype Intermediate Score.


Condition Intervention
Hormone Receptor Positive Malignant Neoplasm of Breast
Device: MammaPrint

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score

Resource links provided by NLM:


Further study details as provided by Agendia:

Primary Outcome Measures:
  • Difference in recommended adjuvant chemotherapy treatment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The frequency of chemotherapy + endocrine versus endocrine alone decisions in Oncotype DX intermediate score patients will be calculated before and after receiving the MammaPrint result. A Chi-square test will be performed for the comparison of the two proportions.


Biospecimen Retention:   Samples With DNA

Patients have the option to agree to the storage of excess samples at Agendia.


Estimated Enrollment: 820
Study Start Date: May 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects with MammaPrint Result Device: MammaPrint
All subjects
Other Name: 70 gene profile

Detailed Description:

The frequency of chemotherapy + endocrine versus endocrine alone decisions in Oncotype DX intermediate score patients will be calculated before and after receiving the MammaPrint result.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with an Intermediate Recurrence Score

Criteria

Inclusion Criteria:

  • Women with histologically proven invasive stage I-II, node negative, hormone receptor positive, Her2 negative breast cancer, who received an Oncotype DX intermediate score (18-30)
  • ≥ 18 years of age at time of consent
  • Written informed consent

Exclusion Criteria:

  • Insufficient tissue remaining for Mammaprint FFPE
  • Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
  • Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617954

Contacts
Contact: Sarah Untch, MS sarah.untch@agendia.com
Contact: Lisette Stork, MSc lisette.stork@agendia.com

  Hide Study Locations
Locations
United States, Alaska
Alaska Clinical Research Center Recruiting
Anchorage, Alaska, United States, 99503
Contact: Talia Wyckoff       taliab@akurological.com   
Principal Investigator: Mark Levandovsky, MD         
United States, Arizona
Maricopa Integrated Health System Recruiting
Phoenix, Arizona, United States
Contact: Marcia Bouton       Marcia_Bouton@dmgaz.org   
Principal Investigator: Ian Komenaka, MD         
United States, California
Providence Saint Joseph Medical Center Recruiting
Burbank, California, United States, 91505
Contact: Veronica Hudson       veronica.hudson@providence.org   
Principal Investigator: Maurice Berkowitz, MD         
Comprehensive Cancer Center Recruiting
Palm Springs, California, United States, 92262
Contact: Claudia Fortiche       claudia.fortiche@tenethealth.com   
Principal Investigator: Laura Lee, MD         
Valley Medical Oncology Consultants Recruiting
Pleasanton, California, United States, 94588
Contact: Manginder Sohal       msohal@vmoc.com   
Principal Investigator: Rishi Sawhney, MD         
Breastlink Recruiting
Santa Ana, California, United States, 92705
Contact: Deidre Carrillo, dcarrillo@breastlink.com         
Principal Investigator: Nimmi Kapoor, MD         
Redwood Regional Cancer Center Recruiting
Santa Rosa, California, United States, 95403
Contact: Kim Young, RN       kyoung@rrmg.com   
Principal Investigator: Charles Elboim, MD         
United States, Colorado
Exempla Saint Joseph Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Nancy Weber, RN       Nancy.Weber@exempla.org   
Principal Investigator: Julie Barone, MD         
United States, Connecticut
Stamford Hospital Recruiting
Stamford, Connecticut, United States, 06902
Contact: Mary Miller       mmiller@stamhealth.org   
Principal Investigator: Paul Weinstein, MD         
United States, Florida
The Breast Institute at JFK Medical Recruiting
Atlantis, Florida, United States, 33462
Contact: Donalyn LaMarre       donalyn.lamarre@hcahealthcare.com   
Principal Investigator: Beth Ann Lesnikoski, MD         
Halifax Health Center for Oncology Recruiting
Daytona Beach, Florida, United States, 32114
Contact: Debbie Reynolds       deborah.reynolds@halifax.org   
Principal Investigator: Ruby A Deveras, MD         
Sub-Investigator: Boon Chew, MD         
Sub-Investigator: Walter Durkin, MD         
Sub-Investigator: Gregory Favis, MD         
Sub-Investigator: Zafar Latif, MD         
Sub-Investigator: Abdul J Sorathia, MD         
Sub-Investigator: Richard Weiss, MD         
Broward Health Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Rowena Dimayuga       Mdimayuga@browardhealth.org   
Principal Investigator: Archana Maini, MD         
Regional Breast/21st Century Oncology Recruiting
Fort Myers, Florida, United States, 33907
Contact: Dr Rock, MD    239-938-9315    drock@rtsx.com   
Principal Investigator: David Rock, MD         
United States, Georgia
Northeast Georgia Cancer Care Recruiting
Athens, Georgia, United States, 30607
Contact: Jamie Hodgson       jhodgson@negacancer.com   
Principal Investigator: Petros Nikolinakos, MD         
Georgia Health Sciences University Recruiting
Augusta, Georgia, United States, 30912
Contact: Melanie Kumrow, RN       mkumrow@georgiahealth.edu   
Principal Investigator: Shefali Shah, MD         
Dekalb Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Ruthie Sweat       ruthie.sweat@dekalbmedical.org   
Principal Investigator: Jayanthi Srinivasiah, MD         
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Patti Rotunda       patti.rotunda@nghs.com   
Principal Investigator: Charles Nash, MD         
United States, Illinois
Loyola University Medical Center Recruiting
Chicago, Illinois, United States
Contact: Kathy Czaplicki       kczapli@lumc.edu   
Principal Investigator: Kathy Albain, MD         
Principal Investigator: Shelly Lo, MD         
Alexian Brothers Medical Center Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Mihaela Banulescu       Mihaela.Banulescu@alexian.net   
Principal Investigator: Stephen Kanter, MD         
Delnor Community Hospital Recruiting
Geneva, Illinois, United States, 60134
Contact: Claudine Gamster       Claudine.Gamster@CadenceHealth.org   
Principal Investigator: Perry Menini, MD         
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Peggy Marriott, RN       mmarriott@ingalls.org   
Principal Investigator: Mark F Kozloff, MD         
CDH Cancer Center Recruiting
Winfield, Illinois, United States, 60190
Contact: Claudia Fredian       claudia.fredian@cadencehealth.org   
Principal Investigator: John Ayers, MD         
United States, Indiana
IU Health Bloomington Recruiting
Bloomington, Indiana, United States, 47402
Contact: Melissa Abbott, RN       mabbott@iuhealth.org   
Principal Investigator: Benjamin Parsons, MD         
Sub-Investigator: Danielle Doyle, MD         
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Lisa Barnaby       lbarnaby@memorialsb.org   
Principal Investigator: Robin Zon, MD         
United States, Iowa
Covenant Medical Center Recruiting
Waterloo, Iowa, United States, 50702
Contact: Kim Maxfield, RN       kimberly.maxfield@wfhc.org   
Principal Investigator: Mukund Nudipuram, MD         
United States, Maryland
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Recruiting
Baltimore, Maryland, United States, 21237
Contact: Jean Flack       jean.flack@medstar.net   
Principal Investigator: Yvonne Ottavio, MD         
Lifebridge Health Recruiting
Baltimore, Maryland, United States
Contact: Melissa Loomis       Mloomis@lifebridgehealth.org   
Principal Investigator: Mayer Gorbaty, MD         
Mercy Medical Center Recruiting
Baltimore, Maryland, United States
Contact: Lisa McConnell       lmcconnell@mdmercy.com   
Principal Investigator: David Riseberg, MD         
MedStar Harbor Hospital Recruiting
Baltimore, Maryland, United States, 21225
Contact: Kristin Brandenburg       Kristin.Y.Brandenburg@Medstar.net   
Principal Investigator: Young Lee, MD         
Western Maryland Health System Recruiting
Cumberland, Maryland, United States, 21502
Contact: Mickie Seletyn, RN       mseletyn@wmhs.com   
Principal Investigator: Blanche Mavromatis, MD         
Sub-Investigator: Alida Podrumar, MD         
United States, Massachusetts
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Kori Hesse       kori.hesse@lahey.org   
Principal Investigator: Corrine Zarwan, MD         
Mount Auburn Hospital Recruiting
Cambridge, Massachusetts, United States, 02144
Contact: Kirsten Chervinsky, RN       kchervin@mah.harvard.edu   
Principal Investigator: Susan Pories, MD         
Sub-Investigator: Lisa Weissman, MD         
MetroWest Medical Center Recruiting
Framingham, Massachusetts, United States, 01702
Contact: Priti Chugh       Priti.Chugh@mwmc.com   
Principal Investigator: Kala Seetharaman, MD         
St. Vincent Hospital Recruiting
Worcester, Massachusetts, United States, 01608
Contact: Marcia Kirkpatrick       marcia.kirkpatrick@reliantmedcalgroup.org   
Principal Investigator: Kerri Bennett, MD         
United States, Michigan
Detroit Clinical Research Center Recruiting
Detroit, Michigan, United States
Contact: Chantel Karmo       chantel.karmo@dcrc.us   
Contact: Vera Dedvukaj       vera.dedvukaj@dcrc.us   
Principal Investigator: Craig Gordon, MD         
United States, Minnesota
Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Lisa Albers       lisa.albers@allina.com   
Principal Investigator: Michaela Tsai, MD         
United States, Missouri
St. Louis Cancer Care Recruiting
Bridgeton, Missouri, United States, 63044
Contact: Kelli Martin       kelli.a.martin@gmail.com   
Principal Investigator: J. Daniel Cuevas, MD         
SSM Cancer Center Recruiting
St. Louis, Missouri, United States, 63117
Contact: Donna Biel       Donna_Bieg@ssmhc.com   
Principal Investigator: Christos Papageorgiou, MD         
United States, Nevada
Comprehensive Caner Centers of Nevada/Summerlin Hospital Recruiting
Las Vegas, Nevada, United States, 89113
Contact: Laura Devine       laura.devine@uhsinc.com   
Principal Investigator: Souzan El-Eid, MD         
United States, New York
Roswell Park Cancer Center Recruiting
Buffalo, New York, United States, 14203
Contact: Mary Ellen Ross       MaryEllen.Ross@RoswellPark.org   
Principal Investigator: Ellis Levine, MD         
North Shore/Monter Cancer Center Recruiting
Lake Success, New York, United States, 11042
Contact: Anthony Calabro       ACalabro@NSHS.edu   
Principal Investigator: Myra Barginear, MD         
Columbia University Recruiting
New York, New York, United States
Contact: Amiya Vaz       av2454@columbia.edu   
Principal Investigator: Sheldon Feldman, MD         
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Ingrid Block, RN       ingrid-block@ouhsc.edu   
Principal Investigator: William Dooley, MD         
Tulsa Cancer Institute Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Jolee Holt       jolee.holt@tciok.org   
Principal Investigator: Scott Cole, MD         
United States, Pennsylvania
St. Mary Medical Center Recruiting
Langhorne, Pennsylvania, United States, 19047
Contact: Christine Armetta       CArmetta@stmaryhealthcare.org   
Principal Investigator: Robert Reilly, MD         
St. Clair Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Contact: Patsy Thompson       patsy.thompson@stclair.org   
Principal Investigator: Raye Budway, MD         
United States, South Carolina
Charleston Cancer Center Recruiting
Charleston, South Carolina, United States, 29406
Contact: Mary Kauser       mary@charlestoncancer.com   
Principal Investigator: Charles Holladay, MD         
United States, Tennessee
Cookeville Regional Medical Center Recruiting
Cookeville, Tennessee, United States, 38501
Contact: Joy Hilliker       jhilliker@crmchealth.org   
Principal Investigator: Paul Jacquin, MD         
Knoxville Comprehensive Breast Center Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Lieasa White       lwhite@knoxvillebreastcenter.com   
Principal Investigator: Kamilia Kozlowski, MD         
Mroz Baier Breast Care Clinic Recruiting
Memphis, Tennessee, United States
Contact: Christine Mroz, MD       mrozbaier@aol.com   
Principal Investigator: Christine Mroz, MD         
Nashville Breast Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Kristie Appleton       kristie@nashvillebreastcenter.com   
Principal Investigator: Pat Whitworth, MD         
United States, Texas
Texas Health Recruiting
Dallas, Texas, United States, 75230
Contact: Suzette Clark       suzetteclark@texashealth.org   
Principal Investigator: Ruben Saez, MD         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Nina Salazar       MNSalazar@HoustonMethodist.org   
Principal Investigator: Angel A Rodriguez, MD         
Sub-Investigator: Daniel Lehane, MD         
Sub-Investigator: Tejal Patel, MD         
Sub-Investigator: Jorge Darcourt, MD         
Cancer Care Centers of South Texas Recruiting
San Antonio, Texas, United States, 78217
Contact: Sharon Wilks, MD       sharon.wilks@usoncology.com   
Principal Investigator: Sharon Wilks, MD         
Sub-Investigator: Alyson Haroff, MD         
START Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Shelly Gunn, MD       shelly.gunn@stoh.com   
Principal Investigator: Shelly Gunn, MD         
United States, Virginia
Hematology/Oncology Associates Recruiting
Alexandria, Virginia, United States
Contact: Vinni Juneja, MD       vinnijuneja@gmail.com   
Principal Investigator: Vinni Juneja, MD         
Rockingham Memorial Hospital Recruiting
Harrisonburg, Virginia, United States, 22801
Contact: Ellen McDonald       Ellen.McDonald.7365@rhcc.com   
Principal Investigator: Heidi Rafferty, MD         
Lynchburg Hematology Oncology Clinic Recruiting
Lynchburg, Virginia, United States, 24501
Contact: Donna Washburn       donna.washburn@centralhealth.com   
Principal Investigator: Dwight Oldham, MD         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Sean McHugh       Sean.McHugh@swedish.org   
Principal Investigator: David Beatty, MD         
Rockwood Clinic Recruiting
Spokane, Washington, United States, 99216
Contact: Marti Wheeler       mwheeler@rockwoodclinic.com   
Principal Investigator: Renu Sinha, MD         
United States, Wisconsin
Columbia St. Mary's Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Kathy Brown, RN       kathleen.brown@columbia-stmarys.org   
Principal Investigator: Charles Tiber, MD         
Wheaton Franciscan Cancer Care - All Saints Recruiting
Racine, Wisconsin, United States, 53405
Contact: Sandy Georgeson       sandra.georgeson@wfhc.org   
Contact: Michelle Czechowicz       michelle.czechowicz@wfhc.org   
Principal Investigator: Young Choi, MD         
Sponsors and Collaborators
Agendia
Investigators
Principal Investigator: Hatem Soliman, MD Moffitt Cancer Center
  More Information

No publications provided

Responsible Party: Agendia
ClinicalTrials.gov Identifier: NCT01617954     History of Changes
Other Study ID Numbers: PROMIS
Study First Received: June 8, 2012
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Recurrence
Neoplasms
Breast Neoplasms
Disease Attributes
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014