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.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Chemosensitivity as defined by pCR
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.
Up to 6 months
No
Pat Whitworth, MD
Principal Investigator
Nashville Breast Center
United States: Institutional Review Board
P0339 NBRST Registry
NCT01479101
July 2011
December 2015
Name | Location |
---|---|
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 |