Women with HER2-positive early-stage breast cancer receiving adjuvant treatment with PB272 (neratinib) may experience severe diarrhea as a side effect, but other agents can control this, according to a new study. The Phase 2 CONTROL trial (NCT02400476) showed that a combination of loperamide, loperamide and budesonide, or loperamide plus colestipol prophylaxis, reduces diarrhea's incidence, severity and duration. Los Angeles-based Puma Biotechnology presented the study, “Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients with HER2+ early-stage breast cancer: the CONTROL trial,” earlier this month at the American Association for Cancer Research (AACR) 2017 Annual Meeting in Washington, D.C. PB272, developed by Puma, is an experimental oral drug for the treatment of breast cancer and other solid tumors. A 2010 report on a Phase 2 clinical trial showed that PB272 by itself benefits HER+ metastatic breast cancer patients. The Phase 3 ExteNET trial (NCT00878709) investigated the effect of PB272 as an adjuvant treatment in women with HER2+ early-stage breast cancer who had previously received Herceptin as an adjuvant. Results showed that 95.4 percent of patients had diarrhea in general, and that 39.8 percent had grade 3 or higher diarrhea. The CONTROL trial is a Phase 2 study investigating whether using loperamide prophylaxis, with or without other agents, may reduce PB272-associated diarrhea.