Phase 2 trial of weight loss responses to pharmacotherapy in breast cancer survivors

Behavioral weight loss (BWL) interventions consisting of remote coaching and self-monitoring have limited effectiveness in breast cancer survivors. The phase 2 Adaptive Nutrition and Exercise Weight Loss (A-NEW) study at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (Baltimore, MD) evaluated addition of Contrave to BWL. Women with prior stage 0 to III breast cancer and a BMI ≥ 27 kg/m² were eligible and initiated BWL. At 2 months, participants with ≥ 5% weight loss (FAST-BWL) continued BWL, whereas those with < 5% weight loss (SLOW-BWL) received BWL plus Contrave. The primary endpoint was proportion SLOW-BWL with ≥ 5% weight loss (WL) at 6 months. Of 55 participants, 2 withdrew prior to 2 months. At 2 months, 15 (28.3%) were FAST-BWL with mean WL of 7.2% (SD 1.5), while 38 (71.7%) were SLOW-BWL, with mean WL 1.2% (SD 2.2). Mean WL between 2 and 6 months was similar in SLOW-BWL (3.8% ± 3.6) and FAST-BWL (3.6% ± 2.6). At 6 months, mean WL was 5.1% (SD 2.9) for SLOW-BWL and 10.8% (3.5) for FAST-BWL; 13 of 15 (86.7%) of FAST-BWL and 16 of 38 (42%) SLOW-BWL had ≥ 5% WL. Physical function and pain improved with ≥5% WL (p=0.03 and p=0.02, respectively). Of 6 withdrawals on Contrave, 1 was due to adverse events. The authors conclude that adding Contrave for breast cancer survivors with minimal initial benefit frow BWL resulted in clinically meaningful WL in 42% following 6 months of treatment.