525 Background: Aromatase inhibitors (AI) are the standard treatment for hormone receptor‐positive breast cancer in postmenopausal women. About half of patients (pts) taking AI suffer from AIA which can be severe enough to cause noncompliance. Suboptimal AI adherence is associated with decreased disease-free and overall survival, suggesting that improving adherence will lead to improved breast cancer outcomes. Effective interventions for AIA are still limited. In clinical trials, tart cherry (TC) showed beneficial effect on musculoskeletal pain associated with osteoarthritis, gout, and strenuous exercise. The flavonoids and anthocyanins in TC reportedly exert an anti-inflammatory effect that may lessen adverse effects of estrogen deficiency. This trial aimed to investigate whether TC can reduce AIA in non-metastatic hormone positive breast cancer (NMHPBC) pts. Methods: This is a randomized, placebo-controlled, double-blind trial. Eligible Pts with NMHPBC on AI for at least 4 weeks were randomized to TC concentrate (equivalent to 50 tart cherries) versus placebo (P) [syrup] in a 1:1 model. Pts were instructed to take 1 Oz of TC or P in 8 Oz water daily for 6 weeks, and to document their pain intensity at baseline, weekly and at study completion in a diary using a Visual Analog Scale (VAS), with 0 mm indicating no pain, and 100 mm indicating highest pain. Results: 60 pts were enrolled from May 2016 to August 2018. 2 pts did not complete the study due to diarrhea. 10 pts were non-compliant. 48 pts were included in the final analysis. TC group (23 pts) had 34.7% mean decrease in pain compared to 1.4% in P group (25 pts). This difference was statistically significant (Mann-Whitney U Test P = 0.034). Conclusions: Tart cherry can significantly improve AIA in non-metastatic breast cancer patients.
A phase 2 randomized, double-blind, placebo-controlled trial of radium-223 dichloride with exemestane and everolimus in patients with HER2–negative hormone receptor–positive breast cancer and bone metastases