NCT02433067.

Trial name or title	Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer (CARDAPAC)
Methods	Study design: RCT Number expected to be randomised: 117 Study start: April 2015; estimated stop date: April 2017 Length of intervention: 12 weeks
Participants	Stage: not specified Time since cancer diagnosis: receiving adjuvant trastuzumab after undergoing surgery for breast cancer Inclusion criteria: First breast cancer HER2 + histologically confirmed WHO grade performance index ≤ 1 Normal renal function (creatinine clearance ≥ 60 mL/min‐1) Normal heart function with LVEF ≥ 50% Normal liver function (AST and ALT normal) Physical activity certificate issued by a cardiologist or an oncologist Active contraception or postmenopausal Age: 18 to 65 years Ethnicity: not reported
Interventions	Participants will participate in a physical activity intervention 3 times per week for 3 months and an interval training programme on a cycle‐ergometer.
Outcomes	Primary objective: To evaluate any change in the left ventricular ejection fraction (LVEF), as evaluated by echocardiography, from baseline to 6 months Secondary objectives: To measure any changes in the following from baseline to 3 months and 6 months: Weight and volume of left and right ventricular by echocardiography Body composition evaluated by impedance and with tape measure and pliers of Harpenden Metabolic responses evaluated with enzyme‐linked immunosorbent assay (ELISA) Maximal voluntary quadriceps evaluated with chair quadriceps with strain gauge Quality of life evaluated with questionnaire Pain evaluated with questionnaire Fatigue evaluated with questionnaire Level of physical activity evaluated with questionnaire Pulmonary function evaluated with respiratory functional test and maximal exercise test Hormonal responses evaluated with ELISA inflammatory responses evaluated with ELISA
Starting date	April 2015
Contact information	Contact: Fabienne Mougin‐Guillaume, PhD; fabienne.mougin‐guillaume@univ‐fcomte.fr Principal Investigator: Nathalie Meneveau
Notes	Country of trial: France https://clinicaltrials.gov/show/NCT02433067