NBRST: Prospective Neo-adjuvant REGISTRY Trial

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01479101

Run by

Agendia

People needed

1142

Starts

2011-07-01

Expected to finish

2021-01-01

Last updated by the study team

2021-01-19

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• 21 Century Oncology — Scottsdale, Arizona, United States
• Alta Bates Summit Comprehensive Cancer Center — Berkeley, California, United States
• Fresno Breast Surgery — Fresno, California, United States
• BreastLink — Long Beach, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Community Hospital of Monterey Peninsula — Monterey, California, United States
• Alta Bates — Oakland, California, United States
• Comprehensive Cancer Center - Palm Springs — Palm Springs, California, United States
• Sutter Roseville Medical Center — Roseville, California, United States
• SHARP Memorial — San Diego, California, United States
• Redwood Regional — Santa Rosa, California, United States
• Wellness Oncology Hematology — West Hills, California, United States
• Wellness Oncology Hematology — West Hills, California, United States
• Exempla Health St Joseph — Denver, Colorado, United States
• Greenwich Hospital — Greenwich, Connecticut, United States
• Stamford Hospital — Stamford, Connecticut, United States
• Halifax Health Center for Oncology — Daytona Beach, Florida, United States
• Florida Hospital Memorial Medical Center — Daytona Beach, Florida, United States
• 21st Century Oncology — Fort Myers, Florida, United States
• St. Vincent Healthcare — Jacksonville, Florida, United States
• The Breast Institute at JFK Medical Center — Lake Worth, Florida, United States
• Baptist Health South Florida — Miami, Florida, United States
• Lakes Research — Miami Lakes, Florida, United States
• Dekalb Medical — Decatur, Georgia, United States
• Arizona Center for Cancer Care — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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