drugset / Trial / NCT00404066
Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC) followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to determine whether lapatinib combined with chemotherapy was safe and resulted in an increase in pathologic complete response rates.
Timeline
- Start
- 2006-10
- Primary completion
- 2010-12
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lapatinib | Small molecule | 1250 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 8 mg | Oral |
| Background | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 300 ug | Subcutaneous |
| Background | filgrastim | Protein / enzyme biologic | 480 ug | Subcutaneous |