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

Phase 4
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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.

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 Responce (pCR) and by centrally assessed
Residual Cancer Burden (RCB).

Inclusion Criteria:

- Women with histologically proven invasive breast cancer and no distant metastases

- lymphnode negative and a clinical tumor classification of T2 (≥3.5cm)-T4 or with 1-3
positive lymph nodes and a clinical tumor classification of T2-T4 DCIS or LCIS are
allowed in addition to invasive cancer at T2 or T3 level.

- Age ≥ 18 years. At least one lesion that can be accurately measured in two dimensions
utilizing mammogram, ultrasound, or MRI images to define specific size and validate
complete pathologic response.

- Adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100
x109/l), adequate renal function (serum creatinine ≤ 1.5 x upper limit of normal) and
hepatic function (ALAT, ASAT ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤
2.5 x upper limit of normal and total bilirubin ≤ 2.0 x upper limit of normal).

- Signed informed consent of the patient

Exclusion Criteria:

- Any patient with confirmed metastatic disease. Patients with inflammatory breast

- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails Quality
Assurance or Quality Control 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Difference in response rate in the molecular subtype categories.

Outcome Time Frame:

6-12 months

Safety Issue:


Principal Investigator

Charles Cox, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Florida


United States: Institutional Review Board

Study ID:




Start Date:

October 2011

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • breast cancer
  • neo adjuvant therapy
  • Breast Neoplasms



Morton Plant Mease Health CareClearwater, Florida  33756
University of South Florida Breast Cancer ProgramTampa, Florida  33613
Plano Cancer InstitutePlano, Texas  75093