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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Cancer
Title   MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint project I (Agendia MINT I) (Cancer)
Description   As part of the patient's normal medical care, the study doctors are using new lab tests (Mammaprint , Blueprint, Theraprint, and Targetprint) to gain more information about the tumor. These genomic tests look at large numbers of normal genes to determine whether they are turned on or off in the tumor tissue. The purpose of this research is to study whether these tests can also be used to predict how well the patient will respond to the chemotherapy.
IRB Number   Pro3959
Inclusion/Notes   INCLUSION:
  • 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:
  • Any patient with confirmed metastatic disease.

  • Patients with inflammatory breast cancer.

  • Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC 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.
Status   Recruiting
Location   Physician / Investigator Office
Principal Name    Ruben Augusto Saez MD
Contact Name   Lee Knox
Phone   (972) 739-3089

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