Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC
Status:
Completed
Trial end date:
2018-01-03
Target enrollment:
Participant gender:
Summary
This was an open-label, single-arm, multi-center, Phase II study to determine the activity of
nab-paclitaxel plus lapatinib in the first and second-line setting in women with ErbB2
overexpressing metastatic breast cancer (MBC). Sixty subjects were to be enrolled in the
study. Subjects were to receive nab-paclitaxel (100 mg/m2 intravenously once weekly for 3
weeks, followed by a rest week in a 4-week cycle) plus lapatinib (1000 mg once daily).
Subjects were to receive treatment until disease progression or withdrawal from the study.
The primary objective of this study was to evaluate overall tumor response rate of lapatinib
in combination with nab-paclitaxel administered in women with ErbB2 overexpressing MBC who
received no chemotherapeutic regimen in the metastatic setting. Secondary objectives included
progression-free survival, overall survival, duration of response, time to response and time
to progression and safety. Safety and efficacy assessments were to be performed at 8 and 12
week intervals, and at the end of treatment.
Subject: Metastatic Breast Cancer, ErbB2, First-line therapy, Lapatinib, Nab-paclitaxel