drugset / Trial / NCT03242616

PemVin vs Vin in Previously Treated Metastatic Breast Cancer

NCT03242616

Phase 2 Completed 17 enrolled Seoul National University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2017-02-17
Primary completion
2023-12-05
Completion
2024-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Pemetrexed Small molecule 500 mg/m2
Comparator Vinorelbine Small molecule 25 mg/m2

Indications