drugset / Trial / NCT01641406
"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate a novel neoadjuvant regimen for invasive breast carcinoma by using the MD Anderson residual cancer burden score.To prospectively evaluate the utility of the PET scan to guide the neoadjuvant treatment and the utility of the Oncotype test as a stratifier for treatment decisons in ER+/Her2- patients. To evaluate the clinical anti-tumor activity of neoadjuvant hormonal therapy in ER+/Her2 negative patients. To evaluate the prognostic factors associated associated with pathological response as measured by the residual cancer burden tool.
Timeline
- Start
- 2011-03
- Primary completion
- 2013-01
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | — | — |
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Docetaxel | Small molecule | — | — |
| Subject | Epirubicin | Small molecule | — | — |
| Subject | Navelbine | Unknown | — | — |
| Subject | Trastuzumab | Monoclonal antibody | — | — |