drugset / Trial / NCT01658358
ErbB2 Positive Metastatic Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Objectives: Phase I part * Primary Objective: To determine the recommended dose of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer. * Secondary Objectives:To define the safety profile; To observe the response rate and progression free survival Phase II part * Primary Objective :To determined the objective response rate of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer. * Secondary Objectives:To define the safety profile; To determined the progression free survival
Timeline
- Start
- 2012-07
- Primary completion
- 2014-09
- Completion
- 2014-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | — | Intravenous |
| Subject | Lapatinib | Small molecule | 1000 mg | Oral |
| Subject | Lapatinib | Small molecule | 1250 mg | Oral |
| Subject | Lapatinib | Small molecule | 1500 mg | Oral |