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

This study is currently recruiting participants.
Verified November 2013 by Agendia
Sponsor:
Information provided by (Responsible Party):
Agendia
ClinicalTrials.gov Identifier:
NCT01617954
First received: June 8, 2012
Last updated: November 13, 2013
Last verified: November 2013
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617954

  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         
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         
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
MedStar Harbor Hospital Recruiting
Baltimore, Maryland, United States, 21225
Contact: Kristin Brandenburg       Kristin.Y.Brandenburg@Medstar.net   
Principal Investigator: Young Lee, MD         
Lifebridge Health Recruiting
Baltimore, Maryland, United States
Contact: Melissa Loomis       Mloomis@lifebridgehealth.org   
Principal Investigator: Mayer Gorbaty, MD         
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         
Mercy Medical Center Recruiting
Baltimore, Maryland, United States
Contact: Lisa McConnell       lmcconnell@mdmercy.com   
Principal Investigator: David Riseberg, 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         
START Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Shelly Gunn, MD       shelly.gunn@stoh.com   
Principal Investigator: Shelly Gunn, 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         
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: November 13, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 14, 2014