MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I — MINT  

Breast Cancer Clinical Trial

Official title: MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I

Status Completed

Clinical Trial Summary

Genomics assays that measure specific gene expression patterns in a patient's primary tumor have become important prognostic tools for breast cancer patients. This study is designed to test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer (LABC).

Clinical Trial Description

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.

Surgical Protocol:

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 Dissection (ALND)

• For node-negative patients: lumpectomy, repeat SLN biopsy (optional), no ALND

Response will be measured by pathological Complete Response (pCR) and by centrally assessed Residual Cancer Burden (RCB). ;

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT01501487
• Study type: Interventional
• Source: Agendia
• Status: Completed
• Phase: Phase 4
• Start date: October 2011
• Completion date: June 2017