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PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score


N/A
18 Years
90 Years
Open (Enrolling)
Female
Hormone Receptor Positive Malignant Neoplasm of Breast

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Trial Information

PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Difference in recommended adjuvant chemotherapy treatment

Outcome 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. A Chi-square test will be performed for the comparison of the two proportions.

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

Hatem Soliman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Moffitt Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

PROMIS

NCT ID:

NCT01617954

Start Date:

May 2012

Completion Date:

August 2015

Related Keywords:

  • Hormone Receptor Positive Malignant Neoplasm of Breast
  • Breast Neoplasms
  • Neoplasms
  • Recurrence

Name

Location

Loyola University Medical CenterMaywood, Illinois  60153
Ingalls Memorial HospitalHarvey, Illinois  60426
Swedish Cancer InstituteSeattle, Washington  98104
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
Northeast Georgia Medical CenterGainesville, Georgia  30501
Washington Cancer InstituteWashington, District of Columbia  20010
Columbia UniversityNew York, New York  10032-3784
Comprehensive Cancer CenterGlendale, California  91204
Charleston Cancer CenterCharleston, South Carolina  29406
Roswell Park Cancer CenterBuffalo, New York  14263
Lahey ClinicBurlington, Massachusetts  01805
The Methodist HospitalHouston, Texas  77030
Mercy Medical CenterBaltimore, Maryland  21202
Santee Hematology/OncologySumter, South Carolina  29150
DeKalb Medical CenterDecatur, Georgia  30033
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Rockwood ClinicSpokane, Washington  99220
Columbia St. Mary's Cancer CenterMilwaukee, Wisconsin  53211
Valley Medical Oncology ConsultantsPleasanton, California  94588
Stamford HospitalStamford, Connecticut  06904
Covenant Medical CenterWaterloo, Iowa  50702
St. Mary Medical CenterLanghorne, Pennsylvania  19047
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Cookeville Regional Medical CenterCookeville, Tennessee  38501
Tennessee OncologyNashville, Tennessee  37203
Wheaton Franciscan Cancer Care - All SaintsRacine, Wisconsin  53405
Nashville Breast CenterNashville, Tennessee  37203
Northeast Georgia Cancer CareAthens, Georgia  30607
Western Maryland Health SystemCumberland, Maryland  21502
St. Vincent HospitalWorcester, Massachusetts  01608
Maricopa Integrated Health SystemPheonix, Arizona  85008
Georgia Health Sciences UniversityAugusta, Georgia  30912
Lynchburg Hematology Oncology ClinicLynchburg, Virginia  24501
Detroit Clinical Research CenterFarmington Hills, Michigan  48336
St. Clair HospitalPittsburgh, Pennsylvania  15243
Texas HealthDallas, Texas  75230
Regional Breast/21st Century OncologyFort Myers, Florida  33907
McAllen OncologyEdinburg, Texas  
Tulsa Cancer InstituteTulsa, Oklahoma  74136
The Breast Institute at JFK MedicalAtlantis, Florida  33462
Halifax Health Center for OncologyDaytona Beach, Florida  32114
University of Florida JacksonvilleJacksonville, Florida  32209
Lifebridge HealthBaltimore, Maryland  
MedStar Harbor HospitalBaltimore, Maryland  21225
Harry & Jeanette Weinberg Cancer Institute at Franklin SquareBaltimore, Maryland  21237
SSM Cancer CenterSt. Louis, Missouri  63117
Comprehensive Caner Centers of Nevada/Summerlin HospitalLas Vegas, Nevada  89113
North Shore/Monter Cancer CenterLake Success, New York  11042
Windsong Comprehensive Breast CareWilliamsville, New York  14221
Knoxville Comprehensive Breast CenterKnoxville, Tennessee  37909
Mroz Baier Breast Care ClinicMemphis, Tennessee  
START CenterSan Antonio, Texas  78229
Hematology/Oncology AssociatesAlexandria, Virginia  
Aurora Cancer CareMilwaukee, Wisconsin  53226