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

18 Years
90 Years
Open (Enrolling)
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

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.


- 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

- 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

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

- 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:


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:


Principal Investigator

Pat Whitworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nashville Breast Center


United States: Institutional Review Board

Study ID:

P0339 NBRST Registry



Start Date:

July 2011

Completion Date:

December 2015

Related Keywords:

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



Swedish Cancer Institute Seattle, Washington  98104
Waukesha Memorial Hospital Waukesha, Wisconsin  53188
Long Beach Memorial Medical Center Long Beach, California  90806
Northeast Georgia Medical Center Gainesville, Georgia  30501
Sutter Roseville Medical Center Roseville, California  95661
University of Nebraska Omaha, Nebraska  68198
Christian Hospital St. Louis, Missouri  63136
Rockwood Clinic Spokane, Washington  99220
Community Hospital of Monterey Peninsula Monterey, California  93940
Stamford Hospital Stamford, Connecticut  06904
St. Mary Medical Center Langhorne, Pennsylvania  19047
Nashville Breast Center Nashville, Tennessee  37203
Advocate Lutheran General Hospital Park Ridge, Illinois  60068
Dallas Surgical Group Dallas, Texas  75235
Great Lakes Cancer Management Specialists Grosse Pointe Woods, Michigan  48236
Blue Ridge Cancer Care Roanoke, Virginia  24019
Virtua Health Vorhees, New Jersey  08043
Coastal Carolina Breast Center Murrells Inlet, South Carolina  29576
Arizona Center for Cancer Care Glendale, Arizona  85306
21st Century Oncology Cape Coral, Florida  33990
Baptist Health South Florida Coral Gables, Florida  33143
Advanced Breast Care Marietta, Georgia  30060
Lynchburg Hematology Oncology Clinic Lynchburg, Virginia  24501
Fresno Breast Surgery Fresno, California  93710
BreastLink Long Beach, California  90806
The Breast Institute at JFK Medical Center Lake Worth, Florida  33461
Center for Breast Care Savannah, Florida  31404
Advanced Breast Care Specialists Bloomingdale, Illinois  60108
University Surgical Consultants Elk Grove Village, Illinois  60007
Northern Indiana Cancer Research South Bend, Indiana  46601
Signature Breast Care Lanham, Maryland  20706
St Lukes Cancer Center Kansas City, Missouri  64111
Ashikari Breast Center Cortlandt Manor, New York  10567
Tolnitch Surgical Associates Raleigh, North Carolina  27607
Breast Care Specialists Allentown, Pennsylvania  18104
St. Clair Hospital Pittsburgh, Pennsylvania  15243
The Breast Place Charleston, South Carolina  29406
Cancer Specialists of Charleston Charleston, South Carolina  29414
Tennesee Cancer Specialists Knoxville, Tennessee  37909
Texas Health Dallas, Texas  75230
Kathryn A. Wagner Private Practice San Antonio, Texas  78205
Virginia Breast Care Charlottesville, Virginia  22911
Surgical Specialists of Northern Virginia Lorton, Virginia  22079
Bon Secours Virginia Breast Center Midlothian, Virginia  23114
Presbyterian Intercommunity Hospital Whittier, California  90602
21 Century Oncology Scottsdale, Arizona  85251
Comprehensive Cancer Center - Palm Springs Palm Springs, California  
SHARP Memorial San Diego, California  
Redwood Regional Santa Rosa, California  
Wellness Oncology Hematology West Hills, California  91307
Dekalb Medical Decatur, Georgia  
Evansville Surgical Associates Evansville, Indiana  47710
Compehensive Cancer Care of Nevada Las Vegas, Nevada  
Texas Tech University Amarillo, Texas  
McAllen Oncology Edinburg, Texas  
East Houston General Surgery Houston, Texas  77396
Radiation Oncology of San Antonio San Antonio, Texas  
Rockingham Memorial Hospital Harrisonburg, Virginia  22801
Columbia St. Marys Cancer Center Milwaukee, Wisconsin  53211
Wheaton Franciscan Healthcare Wauwatosa, Wisconsin  53226