Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
Weight Loss Responses to Pharmacotherapy in Breast Cancer Survivors: Results from the Adaptive Nutrition and Exercise Weight loss (A-NEW) Study.
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Sheng Jennifer Y, Zahurak Marianna L, Too Faith, Montanari Amanda, Trost Jennifer, Lu Mengyang, Lee Young, Parida Sheetal, Blackford Amanda L, Sharma Dipali, Laudenslager Marci, Snyder Claire, Coughlin Janelle W, Stearns Vered
Аннотация
PURPOSE: Behavioral weight loss interventions (BWL) consisting of remote coaching and self-monitoring have limited effectiveness in breast cancer (BC) survivors. We conducted a single-arm phase II study evaluating addition of Contrave® for <5% weight loss (%WL) after 2-months of BWL.
METHODS: Women with prior stage 0-III BC and BMI ≥27 kg/m2 were eligible and initiated BWL. We collected weight, patient-reported outcomes, and labs at baseline, 2- and 6-months. At 2-months, participants with ≥5%WL (FAST-BWL) continued BWL; those with <5%WL (SLOW-BWL) received BWL+Contrave®. The primary endpoint was proportion of SLOW-BWL with ≥5%WL at 6-months, with 30 participants providing 80% power with 5% type I error. Paired t-tests, Kruskal-Wallis tests and mixed-effects models were utilized.
RESULTS: Of 55 participants, 2 withdrew prior to 2-months. At 2-months, 15 (28.3%) were FAST-BWL with mean%WL (SD) of 7.2% (1.5); and 38 (71.7%) were SLOW-BWL with mean%WL of 1.2% (2.2). Mean%WL between 2-6 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% (2.9) for SLOW-BWL and 10.8% (3.5) for FAST-BWL; 13/15 (86.7%) FAST-BWL and 16/38 (42%) SLOW-BWL had ≥5%WL. Physical function and pain improved with ≥5%WL (p=0.03 and p=0.02, respectively). SLOW-BWL had improved HbA1c (p=0.003) and triglycerides (p=0.04). Gastrointestinal symptoms were reported in 74% of SLOW-BWL. Of six withdrawals on Contrave®, one was due to adverse events.
CONCLUSION: Adding Contrave® for BC survivors with minimal initial benefit from BWL results in clinically meaningful weight loss (≥5%) in 42% following 6 months of treatment, which also improves selective cardiometabolic risk factors.
METHODS: Women with prior stage 0-III BC and BMI ≥27 kg/m2 were eligible and initiated BWL. We collected weight, patient-reported outcomes, and labs at baseline, 2- and 6-months. At 2-months, participants with ≥5%WL (FAST-BWL) continued BWL; those with <5%WL (SLOW-BWL) received BWL+Contrave®. The primary endpoint was proportion of SLOW-BWL with ≥5%WL at 6-months, with 30 participants providing 80% power with 5% type I error. Paired t-tests, Kruskal-Wallis tests and mixed-effects models were utilized.
RESULTS: Of 55 participants, 2 withdrew prior to 2-months. At 2-months, 15 (28.3%) were FAST-BWL with mean%WL (SD) of 7.2% (1.5); and 38 (71.7%) were SLOW-BWL with mean%WL of 1.2% (2.2). Mean%WL between 2-6 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% (2.9) for SLOW-BWL and 10.8% (3.5) for FAST-BWL; 13/15 (86.7%) FAST-BWL and 16/38 (42%) SLOW-BWL had ≥5%WL. Physical function and pain improved with ≥5%WL (p=0.03 and p=0.02, respectively). SLOW-BWL had improved HbA1c (p=0.003) and triglycerides (p=0.04). Gastrointestinal symptoms were reported in 74% of SLOW-BWL. Of six withdrawals on Contrave®, one was due to adverse events.
CONCLUSION: Adding Contrave® for BC survivors with minimal initial benefit from BWL results in clinically meaningful weight loss (≥5%) in 42% following 6 months of treatment, which also improves selective cardiometabolic risk factors.