Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments mammaprint 70-gene expression profile, blueprint 80 gene expression profile
Sponsor Agendia
Start date July 2011
End date January 2015
Trial size 1142 participants
Trial identifier NCT01479101, P0339 NBRST Registry

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
All patients receive the MammaPrint and BluePrint gene expression profile. Treatment at the discretion of the physician while adhering to NCCN guidelines.
mammaprint 70-gene expression profile
blueprint 80 gene expression profile

Primary Outcomes

Measure
Chemosensitivity as defined by pCR
time frame: Up to 6 months
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

Secondary Outcomes

Measure
Correlate chemosensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay results.
time frame: Up to 6 months.
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.
Compare local IHC and FISH results (if available) with TargetPrint results.
time frame: Baseline; before start of neo-adjuvant therapy.
Compare the three BluePrint molecular subgroups with IHC-based subtype classification.
time frame: Baseline; before start of neo-adjuvant therapy.
Document impact of MammaPrint, TargetPrint and BluePrint result on treatment decision.
time frame: Baseline; before start neo-adjuvant therapy.

Eligibility Criteria

Female participants from 18 years up to 90 years old.

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

Additional Information

Official title Prospective Neo-adjuvant REGISTRY Trial Linking MammaPrint, Subtyping and Treatment Response: Neoadjuvant Breast Registry - Symphony Trial (NBRST) (Pronounced "in Breast")
Principal investigator Pat Whitworth, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Agendia.