Efficacy and tolerability of BP-C1 in metastatic breast cancer: a Phase II, randomized, double-blind, and placebo-controlled Thai multi-center study.AIMS
 The aim of this study was to compare the efficacy and tolerability of BP-C1 vs equal-looking placebo in metastatic breast cancer.


 Sixteen patients received daily intramuscular injection of 0.035 mg/kg bodyweight of BP-C1 and 15 patients received equal-looking placebo for 32 days.  After 32 days, the placebo patients crossed to BP-C1 with the last observation in the placebo period as baseline.  The sum of target lesion diameters (sum lesions) after 32 days of treatment increased by 8.9% (P=0.08) in the BP-C1 arm compared to 37.6% (P<0.001) in placebo patients.  Twelve of the 15 placebo patients subsequently had BP-C1 treatment.  The sum of CTC-NCI was increased 18.7% in the BP-C1 arm (P=0.38) compared to 50.9% (P=0.04) in placebo patients.  Four mild/moderate adverse events (AEs) present in BP-C1.  The QOL benchmarks "breast cancer problems last week", "sexual interest and activity last 4 weeks", and "breast cancer-related pain and discomfort last week" were stable in the BP-C1 arm but deteriorated in placebo patients.  A total of 32 days of BP-C1 treatment inhibited cancer growth and was well tolerated with few and mainly mild AEs.  The efficacy of BP-C1 was superior in receptor-negative patients.



BP-C1