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Prospective Neo-adjuvant REGISTRY Trial Linking MammaPrint, Subtyping and Treatment Response: Neoadjuvant Breast Registry - Symphony Trial (NBRST) (Pronounced "in Breast")


N/A
18 Years
90 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Prospective Neo-adjuvant REGISTRY Trial Linking MammaPrint, Subtyping and Treatment Response: Neoadjuvant Breast Registry - Symphony Trial (NBRST) (Pronounced "in Breast")


This will be a prospective observational, case-only study linking MammaPrint, BluePrint,
TargetPrint, TheraPrint and possible additional profiles of interest to treatment response
and Distant Metastases Free Survival (DMFS) and Relapse Free Survival (RFS). Only patients
who receive neo-adjuvant therapy can participate.

For this project, approximately 20-30 institutions in the US will be invited to contribute
clinical patient data from enrolled patients after a MammaPrint, TargetPrint, BluePrint and
TheraPrint test has been successfully performed and the patient has started neo-adjuvant
therapy.

Treatment is at the discretion of the physician, adhering to NCCN approved regimens or a
recognized alternative.

The clinical data is to be entered online at 4 time points; amounting to four Case Report
Forms (CRFs). Data will be collected on an ongoing basis, the first CRF must be completed
within 6 weeks after the MammaPrint, BluePrint, TargetPrint, and TheraPrint result was
provided. The second CRF should be completed 4 weeks after definitive surgery. CRF 3 and
CRF4 will be completed 2-3 and 5 years after surgery.

It is expected that we will enroll around 500 patients in 4 years.

OBJECTIVES

- Measure chemosensitivity (as defined by pCR) or endocrine sensitivity (as defined by
decrease in longest tumor diameter or RCB1)in the molecular subgroups as determined by
combining MammaPrint and BluePrint results.

- Correlate chemosensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay
results.

- Compare local IHC and FISH results (if available) with TargetPrint results. Compare the
three BluePrint molecular subgroups with IHC-based subtype classification.

- Document impact of MammaPrint, TargetPrint and BluePrint result on treatment decision.

- Assess the 2-3 and 5 years DMFS and RFS for the different molecular subgroups.

- Measure chemosensitivity or endocrine sensitivity correlation with novel expression
profiles.


Inclusion Criteria:



- Women with histologically proven breast cancer, who have started or are scheduled to
start neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy, after
successful MammaPrint assay

- Age 18-90

- Written informed consent

Exclusion Criteria:

- Patients who have had excisional biopsy or axillary dissection Patients with
confirmed distant metastatic disease

- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC
criteria

- Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for
the treatment of breast cancer

- Any serious uncontrolled intercurrent infections, or other serious uncontrolled
concomitant disease

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Chemosensitivity as defined by pCR

Outcome Description:

For neo-adjuvant chemotherapy patients the primary endpoint is pathological complete response (pCR) which is defined as the absence of invasive carcinoma in both the breast and axilla at microscopic examination of the resection specimen, regardless of the presence of carcinoma in situ. The response rate and corresponding confidence intervals will be presented as a proportion of all patients enrolled. Comparison of response rates between different molecular subgroups will be conducted using Pearson Chi-square test.

Outcome Time Frame:

Up to 6 months

Safety Issue:

No

Principal Investigator

Pat Whitworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nashville Breast Center

Authority:

United States: Institutional Review Board

Study ID:

P0339 NBRST Registry

NCT ID:

NCT01479101

Start Date:

July 2011

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • neo adjuvant, breast cancer
  • Breast Neoplasms

Name

Location

Swedish Cancer InstituteSeattle, Washington  98104
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
Long Beach Memorial Medical CenterLong Beach, California  90806
Northeast Georgia Medical CenterGainesville, Georgia  30501
Sutter Roseville Medical CenterRoseville, California  95661
University of NebraskaOmaha, Nebraska  68198
Christian HospitalSt. Louis, Missouri  63136
Rockwood ClinicSpokane, Washington  99220
Community Hospital of Monterey PeninsulaMonterey, California  93940
Stamford HospitalStamford, Connecticut  06904
St. Mary Medical CenterLanghorne, Pennsylvania  19047
Nashville Breast CenterNashville, Tennessee  37203
Advocate Lutheran General HospitalPark Ridge, Illinois  60068
Dallas Surgical GroupDallas, Texas  75235
Great Lakes Cancer Management SpecialistsGrosse Pointe Woods, Michigan  48236
Blue Ridge Cancer CareRoanoke, Virginia  24019
Virtua HealthVorhees, New Jersey  08043
Coastal Carolina Breast CenterMurrells Inlet, South Carolina  29576
Arizona Center for Cancer CareGlendale, Arizona  85306
21st Century OncologyCape Coral, Florida  33990
Baptist Health South FloridaCoral Gables, Florida  33143
Advanced Breast CareMarietta, Georgia  30060
Lynchburg Hematology Oncology ClinicLynchburg, Virginia  24501
Fresno Breast SurgeryFresno, California  93710
BreastLinkLong Beach, California  90806
The Breast Institute at JFK Medical CenterLake Worth, Florida  33461
Center for Breast CareSavannah, Florida  31404
Advanced Breast Care SpecialistsBloomingdale, Illinois  60108
University Surgical ConsultantsElk Grove Village, Illinois  60007
Northern Indiana Cancer ResearchSouth Bend, Indiana  46601
Signature Breast CareLanham, Maryland  20706
St Lukes Cancer CenterKansas City, Missouri  64111
Ashikari Breast CenterCortlandt Manor, New York  10567
Tolnitch Surgical AssociatesRaleigh, North Carolina  27607
Breast Care SpecialistsAllentown, Pennsylvania  18104
St. Clair HospitalPittsburgh, Pennsylvania  15243
The Breast PlaceCharleston, South Carolina  29406
Cancer Specialists of CharlestonCharleston, South Carolina  29414
Tennesee Cancer SpecialistsKnoxville, Tennessee  37909
Texas HealthDallas, Texas  75230
Kathryn A. Wagner Private PracticeSan Antonio, Texas  78205
Virginia Breast CareCharlottesville, Virginia  22911
Surgical Specialists of Northern VirginiaLorton, Virginia  22079
Bon Secours Virginia Breast CenterMidlothian, Virginia  23114
Presbyterian Intercommunity HospitalWhittier, California  90602
21 Century OncologyScottsdale, Arizona  85251
Comprehensive Cancer Center - Palm SpringsPalm Springs, California  
SHARP MemorialSan Diego, California  
Redwood RegionalSanta Rosa, California  
Wellness Oncology HematologyWest Hills, California  91307
Dekalb MedicalDecatur, Georgia  
Evansville Surgical AssociatesEvansville, Indiana  47710
Compehensive Cancer Care of NevadaLas Vegas, Nevada  
Texas Tech UniversityAmarillo, Texas  
McAllen OncologyEdinburg, Texas  
East Houston General SurgeryHouston, Texas  77396
Radiation Oncology of San AntonioSan Antonio, Texas  
Rockingham Memorial HospitalHarrisonburg, Virginia  22801
Columbia St. Marys Cancer CenterMilwaukee, Wisconsin  53211
Wheaton Franciscan HealthcareWauwatosa, Wisconsin  53226