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

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agendia
• Collaborators: AdventHealth; Florida Hospital; Morton Plant Mease Health Care; Ohio State University Comprehensive Cancer Center; Plano Cancer Center; University of Miami; University of Oklahoma; University of South Alabama; University of South Florida
• Treatments: Albumin-Bound Paclitaxel; Docetaxel; Paclitaxel; Pertuzumab; Trastuzumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.