Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these are largely done before the wide use of premedication (steroid and vitamin B12) for pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer. This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in patients with recurrent or metastatic breast cancer previously treated with or resistant to an anthracycline and taxane.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Vinorelbine (25 mg/m2, day 1 \& 8) * Pemetrexed (500 mg/m2, day 1)
Vinorelbine (25 mg/m2, day 1 \& 8)
Seoul National University Hospital
Seoul, Seoul, South Korea
progression free survival
From date of first dose of study drug till the date of documented progression or death from any cause
Time frame: response assessment every 6 weeks, for up to 2 years
response rate
Proportion of patients with objective response by RECIST version 1.1
Time frame: response assessment every 6 weeks, for up to 2 years
duration of response
Time from documentation of tumor response to disease progression
Time frame: response assessment every 6 weeks, for up to 2 years
overall survival
From date of first dose of study drug till the date of death from any cause
Time frame: up to 2 years
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