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

Completed · Phase 4

Conditions studied: Breast Cancer

In brief

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).

Key facts

Study ID

NCT01501487

Run by

Agendia

People needed

226

Starts

2011-10-01

Expected to finish

2017-06-01

Last updated by the study team

2018-06-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with histologically proven invasive breast cancer and no distant metastases and;
• 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

You may not qualify if…

• Any patient with confirmed metastatic disease. Patients with inflammatory breast cancer.
• 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.

Where it is running

• University of South Alabama, Mitchell Cancer Institute — Mobile, Alabama, United States
• Morton Plant Mease Health Care — Clearwater, Florida, United States
• University of Miami — Miami, Florida, United States
• University of South Florida Breast Cancer Program — Tampa, Florida, United States
• Helen Ellis Memorial Hospital — Tarpon Springs, Florida, United States
• Eastchester Center for Cancer Care — The Bronx, New York, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• University of Oklahoma, Health Sciences Center — Oklahoma City, Oklahoma, United States
• Texas Health, Plano Cancer Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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