drugset / Trial / NCT01501487
MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I
Phase 4
Completed
226 enrolled
Agendia
AdventHealth · collabMorton Plant Mease Health Care · collabOhio State University Comprehensive Cancer Center · collabPlano Cancer Center · collabUniversity of Miami · collabUniversity of Oklahoma · collabUniversity of South Alabama · collabUniversity of South Florida · collab
Non-randomizedParallel-groupOpen-labelDiagnostic
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).
Timeline
- Start
- 2011-10
- Primary completion
- 2016-02
- Completion
- 2017-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Comparator | Epirubicin | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Epirubicin | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Comparator | fluorouracil | Small molecule | 500 mg/m2 | Intravenous |
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Comparator | filgrastim | Protein / enzyme biologic | — | — |