NBRST: Prospective Neo-adjuvant REGISTRY Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Agendia
ClinicalTrials.gov Identifier:
NCT01479101
First received: November 18, 2011
Last updated: June 22, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Breast Cancer
Other: MammaPrint 70-gene expression profile
Other: BluePrint 80 gene expression profile

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Neo-adjuvant REGISTRY Trial Linking MammaPrint, Subtyping and Treatment Response: Neoadjuvant Breast Registry - Symphony Trial (NBRST) (Pronounced "in Breast")

Resource links provided by NLM:


Further study details as provided by Agendia:

Primary Outcome Measures:
  • Chemosensitivity as defined by pCR [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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.

  • Endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Correlate chemosensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay results. [ Time Frame: Up to 6 months. ] [ Designated as safety issue: No ]
    Correlation of chemosensitivity and endocrine sensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay results will be determined using Pearson correlation and linear fit models.

  • Assess metastasis-free survival and relapse-free survival in molecular subgroups, determined by the established MammaPrint, BluePrint, profiles. [ Time Frame: At -2-3 years and 5 years after definitive surgery. ] [ Designated as safety issue: No ]

    Kaplan-Meier curves for DMFS will be calculated for the following eight subgroups

    1. Luminal subtype
    2. ERBB2 subtype
    3. Basal subtype
    4. Luminal subtype and high risk MammaPrint
    5. Luminal subtype and low risk MammaPrint
    6. ERBB2 subtype and high risk MammaPrint
    7. ERBB2 subtype and low risk MammaPrint

  • Compare local IHC and FISH results (if available) with TargetPrint results. [ Time Frame: Baseline; before start of neo-adjuvant therapy. ] [ Designated as safety issue: No ]
    Correlation of TargetPrint ER, PR, and HER2 microarray readout with IHC/FISH assessment will be determined using Pearson correlation and linear fit models. Agreement measurements between binary microarray and IHC classifications will be based on 2-way contingency table analysis and include overall concordance, positive agreement defined as the number of samples classified positive by both IHC and TargetPrint divided by the number of positive samples using IHC, negative agreement and Cohen's Kappa coefficient score.

  • Compare the three BluePrint molecular subgroups with IHC-based subtype classification. [ Time Frame: Baseline; before start of neo-adjuvant therapy. ] [ Designated as safety issue: No ]
  • Document impact of MammaPrint, TargetPrint and BluePrint result on treatment decision. [ Time Frame: Baseline; before start neo-adjuvant therapy. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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.


Enrollment: 1142
Study Start Date: July 2011
Estimated Study Completion Date: January 2020
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: MammaPrint 70-gene expression profile Other: BluePrint 80 gene expression profile

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479101

  Hide Study Locations
Locations
United States, Arizona
Arizona Center for Cancer Care
Glendale, Arizona, United States, 85306
21 Century Oncology
Scottsdale, Arizona, United States, 85251
United States, California
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94705
Fresno Breast Surgery
Fresno, California, United States, 93710
BreastLink
Long Beach, California, United States, 90806
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Community Hospital of Monterey Peninsula
Monterey, California, United States, 93940
Alta Bates
Oakland, California, United States, 94609
Comprehensive Cancer Center - Palm Springs
Palm Springs, California, United States
Sutter Roseville Medical Center
Roseville, California, United States, 95661
SHARP Memorial
San Diego, California, United States
Redwood Regional
Santa Rosa, California, United States
Wellness Oncology Hematology
West Hills, California, United States, 91307
Wellness Oncology Hematology
West Hills, California, United States
United States, Colorado
Exempla Health St Joseph
Denver, Colorado, United States, 80218
United States, Connecticut
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Stamford Hospital
Stamford, Connecticut, United States, 06902
United States, Florida
Florida Hospital Memorial Medical Center
Daytona Beach, Florida, United States, 32117
Halifax Health Center for Oncology
Daytona Beach, Florida, United States, 32114
21st Century Oncology
Fort Myers, Florida, United States, 33907
St. Vincent Healthcare
Jacksonville, Florida, United States, 322004
The Breast Institute at JFK Medical Center
Lake Worth, Florida, United States, 33461
Baptist Health South Florida
Miami, Florida, United States, 33183
Lakes Research
Miami Lakes, Florida, United States, 33014
Center for Breast Care
Savannah, Florida, United States, 31404
United States, Georgia
Dekalb Medical
Decatur, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Illinois
Advanced Breast Care Specialists
Bloomingdale, Illinois, United States, 60108
University Surgical Consultants
Elk Grove Village, Illinois, United States, 60007
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Hematology/Oncology of The North Shore
Skokie, Illinois, United States, 60076
United States, Indiana
Evansville Surgical Associates
Evansville, Indiana, United States, 47710
Northern Indiana Cancer Research
South Bend, Indiana, United States, 46601
United States, Louisiana
Willis-Knighton Cancer Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Signature Breast Care
Lanham, Maryland, United States, 20706
United States, Michigan
McLaren Health Care
Burton, Michigan, United States, 48509
Great Lakes Cancer Management Specialists
Gross Point Woods, Michigan, United States, 48236
Providence Cancer Institute
Southfield, Michigan, United States, 48075
United States, Missouri
St Lukes Cancer Center
Kansas City, Missouri, United States, 64111
Christian Hospital
St Louis, Missouri, United States, 63136
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198
United States, Nevada
Compehensive Cancer Care of Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Virtua Health
Willingboro, New Jersey, United States, 08046
United States, New York
Ashikari Breast Center
Cortlandt Manor, New York, United States, 10567
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Theresa & Eugene M. Lang Research Center
Flushing, New York, United States, 11355
United States, Ohio
Akron General Hospital
Akron, Ohio, United States, 44302
University of Toledo
Toledo, Ohio, United States, 43614
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Breast Care Specialists
Allentown, Pennsylvania, United States, 18104
ACMH Cancer Center
Kittanning, Pennsylvania, United States, 16201
St. Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
St. Clair Hospital
Pittsburgh, Pennsylvania, United States, 15243
United States, South Carolina
Cancer Specialists of Charleston
Charleston, South Carolina, United States, 29414
The Breast Place
Charleston, South Carolina, United States, 29406
Coastal Carolina Breast Center
Murrells Inlet, South Carolina, United States, 29576
United States, Tennessee
Nashville Breast Center
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Tech University
Amarillo, Texas, United States
Austin Cancer Center
Austin, Texas, United States, 78303
Dallas Surgical Group
Dallas, Texas, United States, 75230
Texas Health
Dallas, Texas, United States, 75230
McAllen Oncology
Edinburg, Texas, United States
East Houston General Surgery
Houston, Texas, United States, 77396
Kathryn A. Wagner Private Practice
San Antonio, Texas, United States, 78205
Radiation Oncology of San Antonio
San Antonio, Texas, United States
United States, Virginia
Virginia Breast Care
Charlottesville, Virginia, United States, 22911
Virginia Breast Care
Charlottsville, Virginia, United States, 22911
Rockingham Memorial Hospital
Harrisonburg, Virginia, United States, 22801
Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, United States, 24501
Bon Secours Virginia Breast Center
Midlothian, Virginia, United States, 23114
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Rockwood Clinic
Spokane, Washington, United States, 99216
United States, Wisconsin
Bellin Hospital
Green Bay, Wisconsin, United States, 54313
Columbia St. Marys Cancer Center
Milwaukee, Wisconsin, United States, 53211
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Wheaton Franciscan Healthcare
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Agendia
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Agendia
ClinicalTrials.gov Identifier: NCT01479101     History of Changes
Other Study ID Numbers: P0339 NBRST Registry
Study First Received: November 18, 2011
Last Updated: June 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Agendia:
neo adjuvant, breast cancer

ClinicalTrials.gov processed this record on August 02, 2015