Phase I/II Study of Lapatinib in Combination With Oral Vinorelbine for Metastatic Breast Cancer
This is a phase I/II clinical trial. In phase I part, the primary objective is To determine
the recommended dose of the combination of lapatinib with oral vinorelbine in patients with
ErbB2 positive metastatic breast cancer. In phase II part, the primary objective is
progression free survival of the combination of lapatinib with oral vinorelbine as first
line chemotherapy in patients with ErbB2 positive metastatic breast cancer. The secondary
objectives are safety profile and the response rate
Lapatinib, an oral inhibitor of EGFR and HER2, have been shown to be an effective treatment
in HER2/neu overexpressing metastatic breast cancer patient who refractory herceptin,
taxane, and anthracycline treatment. In pre-clinical studies, the highest synergism between
anti-Her2 treatment (trastuzumab) and cytotoxics was seen with the platinum compounds and
with vinorelbine. The oral vinorelbine has similar efficacy to that of the injection
formulation and has demonstrated generally favorable tolerability. We are interested in
lapatinib plus oral vinorelbine as 1st line treatment in Her2+ MBC, to which we believe this
convenience treatment offer a good response rate with satisfactory life quality.
For phase I part, we plan to use the standard phase I 3-patient cohort (''3 + 3'') design.
Up to 18 patients may be enrolled. For phase II part, the expected progression-free survival
of the protocol treatment in first line treatment of ErbB2 positive metastatic breast cancer
is more than 6 months. With type 1 and type 2 errors of 0.05 and 0.1, respectively, this
design calls for 29 patients at the first stage. If 20 or more progression disease is
observed after 6 months of treatment, then the study will be terminated. Otherwise,
additional 25 patients will be entered at the second stage. The treatment will be rejected
if a total of 37 or more progression disease are observed out of 54 patients after 6 months
of treatment. With the estimated dropout rate of 10%, 32 patients will be accrued in the
first stage and 28 in the second stage.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the recommended dose of the combination of oral lapatinib with vinorelbine (phase I part), and progression free survival (phase II part)
phase I part: 4 months, phase II part: 1 and half years
Yes
Yen-Shen Lu, M.D.,Ph.D
Principal Investigator
Department of Oncology,National Taiwan University Hospital
Taiwan: Department of Health
200811019M
NCT00912275
May 2009
December 2013
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