MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I
Patients with suspected primary breast cancer on mammography and clinical examination will
be assessed for eligibility by having a needle core biopsy to confirm invasive carcinoma.
A fresh unfixed tumor specimen, incisional or core biopsy will be sent to Agendia to
determine the MammaPrint risk profile, the BluePrint molecular subtyping profile, the
TargetPrint ER, PR and HER2 single gene readout, the 56-geneTheraPrint Research Gene Panel
and the additional genes as measured on the whole genome (44k) array.
1. Determination of nodal status:
- For clinically node-negative patients: Axillary ultra sound, followed by Sentinel
Lymph Node (SLN) biopsy
- For clinically node-positive patients: ultra sound-guided Fine Needle Aspirate
(FNA), followed by core biopsy
2. Neo-adjuvant chemotherapy
3. Definitive surgery:
- For node-positive patients: lumpectomy, repeat SLN biopsy, Axillary Lymph Node
- For node-negative patients: lumpectomy, repeat SLN biopsy (optional), no ALND
Response will be measured by pathological Complete Responce (pCR) and by centrally assessed
Residual Cancer Burden (RCB).
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Difference in response rate in the molecular subtype categories.
Charles Cox, MD
University of South Florida
United States: Institutional Review Board
|Morton Plant Mease Health Care||Clearwater, Florida 33756|
|University of South Florida Breast Cancer Program||Tampa, Florida 33613|
|Plano Cancer Institute||Plano, Texas 75093|