PURPOSE: To evaluate the feasibility of a home-based moderate-to-vigorous intensity, phased (introduction, intermediate, maintenance), exercise prescription in breast cancer patients receiving cardiotoxic neoadjuvant chemotherapy. METHODS: Nineteen breast cancer patients were randomized to intervention or control for the duration of chemotherapy (16 to 24 weeks). The intervention was one aerobic exercise session at 80 to 90% VO2max for 25 min/week and 65% to 75% VO2max for >= 50 min/week. Adherence to the tailored home-based program was assessed by heart rate monitors. Acceptability, tolerability, feasibility, efficacy, change in VO2max, and patient reported outcomes, safety, and clinical events were assessed. RESULTS: 25.7% of eligible women consented (acceptability). Adherence was 87.6%. Women were not able to maintain exercise intensity as chemotherapy progressed (23.7% of exercise minutes were completed at prescribed heart rate during maintenance). Efficacy of the intervention was demonstrated by maintenance of VO2max (-1.0 +/- 13.2%) compared to (-27.5 +/- 7.4%) the control group. Further, during and after therapy, patients in the intervention arm reported less fatigue (control-baseline: 14.4 +/- 15.9; midpoint: 19.0 +/- 11.4; follow-up: 29.4 +/- 20.0; intervention-baseline: 29.2 +/- 24.6; midpoint: 24.6 +/- 14.4; follow-up: 23.6 +/- 11.9), impairment in activities (control-baseline: 13.7 +/- 16.0; midpoint: 32.8 +/- 17.0; follow-up: 58.6 +/- 27.9; intervention-baseline: 38.7 +/- 31.8; midpoint: 47.1 +/- 27.5; follow-up: 47.5 +/- 31.0), and pain (control-baseline: 80.8 +/- 17.1; midpoint: 73.9 +/- 20.7; follow-up: 50.7 +/- 25.7; intervention-baseline: 68.7 +/- 28.4; midpoint: 61.4 +/- 22.5; follow-up: 65.3 +/- 22.4). There were no differences in adverse events, treatment delays, or pathological complete response. CONCLUSIONS: Neoadjuvant breast cancer patients maintained approximately one hour/week of moderate-intensity exercise over the course of their treatment. Further, this volume of exercise was sufficient to maintain fitness capacity and quality of life compared to the control group. TRIAL REGISTRY: ClinicalTrials.gov Identifier: NCT03280836, prospectively registered 9/13/2017, https://clinicaltrials.gov/ct2/show/NCT03280836.

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