NBRST: Prospective Neo-adjuvant REGISTRY Trial
NBRST
Prospective Neo-adjuvant REGISTRY Trial Linking MammaPrint, Subtyping and Treatment Response: Neoadjuvant Breast Registry - Symphony Trial (NBRST) (Pronounced "in Breast")
1 other identifier
observational
1,142
1 country
76
Brief Summary
The scope of this registry study is to measure chemosensitivity as defined by pCR (primary endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy), metastasis-free survival and relapse-free survival(secondary endpoints) in molecular subgroups, determined by the established MammaPrint, BluePrint, Targetprint and Theraprint profiles in addition to possible novel expression profiles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Longer than P75 for all trials
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedJanuary 19, 2021
January 1, 2021
3.5 years
November 18, 2011
January 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1)
The primary endpoint for patients with neo-adjuvant hormonal therapy is partial response which is defined as decrease in longest tumor diameter. 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
Secondary Outcomes (5)
Correlate chemosensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay results.
Up to 6 months.
Assess metastasis-free survival and relapse-free survival in molecular subgroups, determined by the established MammaPrint, BluePrint, profiles.
At -2-3 years and 5 years after definitive surgery.
Compare local IHC and FISH results (if available) with TargetPrint results.
Baseline; before start of neo-adjuvant therapy.
Compare the three BluePrint molecular subgroups with IHC-based subtype classification.
Baseline; before start of neo-adjuvant therapy.
Document impact of MammaPrint, TargetPrint and BluePrint result on treatment decision.
Baseline; before start neo-adjuvant therapy.
Study Arms (1)
MammaPrint, BluePrint, neo-adj CT or HT
All patients receive the MammaPrint and BluePrint gene expression profile. Treatment at the discretion of the physician while adhering to NCCN guidelines.
Interventions
Eligibility Criteria
Women with histologically proven breast cancer, who have started or are scheduled to start neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agendialead
Study Sites (76)
Arizona Center for Cancer Care
Glendale, Arizona, 85306, United States
21 Century Oncology
Scottsdale, Arizona, 85251, United States
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, 94705, United States
Fresno Breast Surgery
Fresno, California, 93710, United States
BreastLink
Long Beach, California, 90806, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Community Hospital of Monterey Peninsula
Monterey, California, 93940, United States
Alta Bates
Oakland, California, 94609, United States
Comprehensive Cancer Center - Palm Springs
Palm Springs, California, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
SHARP Memorial
San Diego, California, United States
Redwood Regional
Santa Rosa, California, United States
Wellness Oncology Hematology
West Hills, California, 91307, United States
Wellness Oncology Hematology
West Hills, California, United States
Exempla Health St Joseph
Denver, Colorado, 80218, United States
Greenwich Hospital
Greenwich, Connecticut, 06830, United States
Stamford Hospital
Stamford, Connecticut, 06902, United States
Halifax Health Center for Oncology
Daytona Beach, Florida, 32114, United States
Florida Hospital Memorial Medical Center
Daytona Beach, Florida, 32117, United States
21st Century Oncology
Fort Myers, Florida, 33907, United States
St. Vincent Healthcare
Jacksonville, Florida, 322004, United States
The Breast Institute at JFK Medical Center
Lake Worth, Florida, 33461, United States
Baptist Health South Florida
Miami, Florida, 33183, United States
Lakes Research
Miami Lakes, Florida, 33014, United States
Dekalb Medical
Decatur, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Center for Breast Care
Savannah, Georgia, 31404, United States
Advanced Breast Care Specialists
Bloomingdale, Illinois, 60108, United States
University Surgical Consultants
Elk Grove Village, Illinois, 60007, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Hematology/Oncology of The North Shore
Skokie, Illinois, 60076, United States
Evansville Surgical Associates
Evansville, Indiana, 47710, United States
Northern Indiana Cancer Research
South Bend, Indiana, 46601, United States
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103, United States
Signature Breast Care
Lanham, Maryland, 20706, United States
McLaren Health Care
Burton, Michigan, 48509, United States
Great Lakes Cancer Management Specialists
Grosse Pointe Woods, Michigan, 48236, United States
Providence Cancer Institute
Southfield, Michigan, 48075, United States
St Lukes Cancer Center
Kansas City, Missouri, 64111, United States
Christian Hospital
St Louis, Missouri, 63136, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
Compehensive Cancer Care of Nevada
Las Vegas, Nevada, 89128, United States
Virtua Health
Willingboro, New Jersey, 08046, United States
Ashikari Breast Center
Cortlandt Manor, New York, 10567, United States
Hematology Oncology Associates of Central New York
East Syracuse, New York, 13057, United States
Theresa & Eugene M. Lang Research Center
Flushing, New York, 11355, United States
Akron General Hospital
Akron, Ohio, 44302, United States
University of Toledo
Toledo, Ohio, 43614, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Breast Care Specialists
Allentown, Pennsylvania, 18104, United States
ACMH Cancer Center
Kittanning, Pennsylvania, 16201, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
St. Clair Hospital
Pittsburgh, Pennsylvania, 15243, United States
The Breast Place
Charleston, South Carolina, 29406, United States
Cancer Specialists of Charleston
Charleston, South Carolina, 29414, United States
Coastal Carolina Breast Center
Murrells Inlet, South Carolina, 29576, United States
Nashville Breast Center
Nashville, Tennessee, 37203, United States
Texas Tech University
Amarillo, Texas, United States
Austin Cancer Center
Austin, Texas, 78303, United States
Dallas Surgical Group
Dallas, Texas, 75230, United States
Texas Health
Dallas, Texas, 75230, United States
McAllen Oncology
Edinburg, Texas, United States
East Houston General Surgery
Houston, Texas, 77396, United States
Kathryn A. Wagner Private Practice
San Antonio, Texas, 78205, United States
Radiation Oncology of San Antonio
San Antonio, Texas, United States
Virginia Breast Care
Charlottesville, Virginia, 22911, United States
Rockingham Memorial Hospital
Harrisonburg, Virginia, 22801, United States
Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, 24501, United States
Bon Secours Virginia Breast Center
Midlothian, Virginia, 23114, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Rockwood Clinic
Spokane, Washington, 99216, United States
Bellin Hospital
Green Bay, Wisconsin, 54313, United States
Columbia St. Marys Cancer Center
Milwaukee, Wisconsin, 53211, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Wheaton Franciscan Healthcare
Wauwatosa, Wisconsin, 53226, United States
Related Publications (2)
Whitworth PW, Beitsch PD, Murray MK, Richards PD, Mislowsky A, Dul CL, Pellicane JV, Baron PL, Rahman RL, Lee LA, Dupree BB, Kelemen PR, Ashikari AY, Budway RJ, Lopez-Penalver C, Dooley W, Wang S, Dauer P, Menicucci AR, Yoder EB, Finn C, Blumencranz LE, Audeh W. Genomic Classification of HER2-Positive Patients With 80-Gene and 70-Gene Signatures Identifies Diversity in Clinical Outcomes With HER2-Targeted Neoadjuvant Therapy. JCO Precis Oncol. 2022 Sep;6:e2200197. doi: 10.1200/PO.22.00197.
PMID: 36108259DERIVEDWhitworth PW, Beitsch PD, Pellicane JV, Baron PL, Lee LA, Dul CL, Murray MK, Gittleman MA, Budway RJ, Rahman RL, Kelemen PR, Dooley WC, Rock DT, Cowan KH, Lesnikoski BA, Barone JL, Ashikari AY, Dupree BB, Wang S, Menicucci AR, Yoder EB, Finn C, Corcoran K, Blumencranz LE, Audeh W; NBRST Investigators Group. Distinct Neoadjuvant Chemotherapy Response and 5-Year Outcome in Patients With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Tumors That Reclassify as Basal-Type by the 80-Gene Signature. JCO Precis Oncol. 2022 Apr;6(1):e2100463. doi: 10.1200/PO.21.00463.
PMID: 35476550DERIVED
Biospecimen
As part of routine breast cancer treatment, the doctor will conduct a core needle biopsy and provide tissue from the tumor to Agendia for testing. After the diagnostic test(s) from the Agendia Breast Cancer Suite have been performed on the tumor specimen, there might be some remaining tissue left.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pat Whitworth, MD
Nashville Breast Center
- PRINCIPAL INVESTIGATOR
Stephanie Akbari, MD
Reinsch Pierce Family Center for Breast Health
- PRINCIPAL INVESTIGATOR
Mark Gittleman, MD
Breast Care Specialists
- PRINCIPAL INVESTIGATOR
Peter Beitsch, MD
Dallas Surgical Group
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2011
First Posted
November 24, 2011
Study Start
July 1, 2011
Primary Completion
January 1, 2015
Study Completion
January 1, 2021
Last Updated
January 19, 2021
Record last verified: 2021-01