NBRST: Prospective Neo-adjuvant REGISTRY Trial



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 90
Updated:6/29/2018
Start Date:July 2011
End Date:January 2020

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

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.

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 50-70 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 1000 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
We found this trial at
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Pittsburgh, Pennsylvania 15243
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Akron, Ohio 44302
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Allentown, Pennsylvania 18104
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Amarillo, Texas
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Austin, Texas 78303
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2450 Ashby Ave.
Berkeley, California 94705
(510) 204-4444
Alta Bates Summit Comprehensive Cancer Center Our Comprehensive Cancer Services are comprised of exceptional, state-of-the-art...
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Bloomingdale, Illinois 60108
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Burton, Michigan 48509
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Charleston, South Carolina 29414
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Charleston, South Carolina 29406
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Charlottesville, Virginia 22911
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Cortlandt Manor, New York 10567
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Dallas, Texas 75235
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Dallas, Texas 75230
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Daytona Beach, Florida 32117
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Daytona Beach, Florida 32114
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Decatur, Georgia
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Denver, Colorado 80218
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Edinburg, Texas 78539
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Elk Grove Village, Illinois 60007
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Evansville, Indiana 47710
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Flushing, New York 11355
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Fort Myers, Florida 33907
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Fresno, California 93710
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743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
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Glendale, Arizona 85306
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744 South Webster Avenue
Green Bay, Wisconsin 54313
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Greenwich, Connecticut 06830
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Grosse Pointe Woods, Michigan 48236
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Harrisonburg, Virginia 22801
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Houston, Texas 77396
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Jacksonville, Florida 32200
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Kansas City, Missouri 64111
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Kittanning, Pennsylvania 16201
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Lake Worth, Florida 33461
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Langhorne, Pennsylvania 19047
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Lanham, Maryland 20706
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Long Beach, California 90806
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Long Beach, California 90801
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1701 Thomson Dr #200
Lynchburg, Virginia 24501
(434) 200-5925
Lynchburg Hematology-Oncology Clinic Lynchburg Hematology Oncology is a medical oncology and hematology practice located on...
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Miami, Florida 33183
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Miami Lakes, Florida 33014
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Midlothian, Virginia 23114
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Midlothian, Virginia 23114
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Milwaukee, Wisconsin 53211
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Murrells Inlet, South Carolina 29576
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Nashville, Tennessee 37203
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Oakland, California 94609
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
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Omaha, Nebraska 68198
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1775 West Dempster Street
Park Ridge, Illinois 60068
(847) 723-2210
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Roseville, California 95661
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Saint Louis, Missouri 63136
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San Antonio, Texas 78205
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San Diego, California 92123
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Savannah, Florida 31404
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Scottsdale, Arizona 85251
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Seattle, Washington 98104
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Shreveport, Louisiana 71103
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South Bend, Indiana 46601
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Southfield, Michigan 48075
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Spokane, Washington 99204
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Stamford, Connecticut 06904
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
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Waukesha, Wisconsin 53188
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Wauwatosa, Wisconsin 53226
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West Hills, California
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Willingboro, New Jersey 08046
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