LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
This single center Phase I dose escalation trial will evaluate the safety, tolerability and
efficacy of LBH589 when combined with capecitabine and lapatinib in three parts. Part 1 will
determine the maximum tolerated doses (MTD) of LBH589 when combined with capecitabine. Parts
2 and 3 will be limited to locally recurrent or metastatic breast cancer patients, ICH 3+
overexpression or FISH amplification documented locally. Part 2 will evaluate the safety of
the MTD of LBH589 determined in Part 1 when paired with lapatinib 1000 mg by mouth (PO)
daily. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer
patients, ICH 3+ overexpression or FISH amplification documented locally. Part 3 will
evaluate the tolerability and effectiveness of the triplet combination, LBH589, capecitabine
and lapatinib in breast cancer patients.