Status:
COMPLETED
MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I
Lead Sponsor:
Agendia
Collaborating Sponsors:
University of South Florida
University of Miami
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 abilit...
Detailed 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 tu...
Eligibility Criteria
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 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT01501487
Start Date
October 1 2011
End Date
June 1 2017
Last Update
June 28 2018
Active Locations (9)
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1
University of South Alabama, Mitchell Cancer Institute
Mobile, Alabama, United States, 36688
2
Morton Plant Mease Health Care
Clearwater, Florida, United States, 33756
3
University of Miami
Miami, Florida, United States, 33124
4
University of South Florida Breast Cancer Program
Tampa, Florida, United States, 33613