Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone
Status:
Terminated
Trial end date:
2018-03-30
Target enrollment:
Participant gender:
Summary
This was a randomized, open-label, multi-center Phase III study evaluating the efficacy and
safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued
HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC). Eligible
subjects should have completed 12 to 24 weeks of first- or second-line treatment with
trastuzumab plus chemotherapy, experienced either complete disappearance of all metastatic
lesions, or persistence of metastatic disease (stable disease) without unequivocal
progression or the occurrence of new lesions, and been indicated to continue to receive
trastuzumab alone as maintenance therapy. Eligible subjects who entered the LPT112515 study
on first-line treatment should not have known history of central nervous system (CNS)
metastases; subjects who entered the study on second-line treatment should not have known
history of CNS metastases or have stable (asymptomatic and off steroids ≥3 months) CNS
metastases. The primary objective of this study was to compare progression-free survival
(PFS) in subjects with HER2-positive MBC randomized to receive treatment with lapatinib plus
trastuzumab versus those randomized to receive trastuzumab alone. The secondary objectives
included overall survival, clinical benefit response rate (CR, PR or SD ≥24 weeks) and the
qualitative and quantitative adverse event profile of the 2 treatment arms. It was estimated
that 280 subjects (140 per group) would be required to observe 193 PFS events.