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Background: MoviS: ‘Movement and Health Beyond Care’ is a 3-year randomized controlled trial aiming to educate cancer patients after adjuvant therapy on the benefits of personalized physical activity (PA) and a proper nutritional plan Methods: In this project, breast cancer (BC) patients who consent to participate will be randomized to Interventional Arm (A), consisting of 3-months of Movis Training, or Control Arm (B), consisting of standard care with no supervised PA The Movis Training consists of 3-months of aerobic training (2 d/week of supervised training and 1 d/week of unsupervised exercise) with an increase in exercise intensity (40-70% Heart Rate Reserve) and duration (20-60 min) Ad interim analyses every 3-months up to 1-year will be included The first cohort of eligible BC survivors were enrolled in January 2020 and carried out the Movis Training even during the COVID-19 pandemic The primary outcome is improvement of Quality of Life (QoL) assessed by European Organization for Research and Treatment of Cancer QoL (EORTC QLQ-C30) The secondary outcomes are improvement of health-related QoL parameters such as: PA level (International Physical Activity Questionnaire;SenseWear Armband), fitness (VO2max), flexibility, strength, psychological well-being (Psychological distress Inventory;Profile of Mood States and diet habit (DianaWeb, MEDIET modified and recall 24h);Anthropometric measurement, Body mass (kg);BMI (kg/m2);body composition Results: The expected improvement (mean ± SD) of the QoL in Arm A at 3-months is 15 1 ± 17 7, while in Arm B is 6 1 ± 17 1 (Cohen d effect size=0 51, medium effect) Using a t test for independent samples, with 0 05 alpha and 0 80 1-beta will require 60 subjects per group Considering an expected drop-out of 30%, a total of 172 patients will be recruited Conclusions: The targeted exercise oncology through multidisciplinary team would like to provide a coordinated program of cancer care to improve health care quality, improve prognosis, increase survival times and QoL and reduce the risk of BC recurrence Legal entity responsible for the study: Elena Barbieri Funding: Has not received any funding Disclosure: All authors have declared no conflicts of interest

Background Combined endocrine/targeted approaches have been investigated as first-line treatment in hormone receptors positive metastatic breast cancer (BC). Randomized trials showed that the addiction of CDK (cyclin-dependent kinase) 4/6 inhibitors to endocrine therapy (ET) increase progression free survival (PFS). Elderly patients (aged >65 years) are under represented in most of the trials. Due to the multi-morbidity and the major toxicity associated with the targeted agents, the combination strategy in that subgroup is widely discussed. The present meta-analysis aimed to understand the role of the new endocrine approaches in elderly women. Methods This meta-analysis included first line phase II/III randomized published trials comparing ET to the experimental strategy. Trials with no data about hazard ratios (HR) for PFS in the subgroup of patients aged > 65 years were excluded. The heterogeneity of the data was evaluated by Chi-square Q test and I2 statistic. Prospero registration number: CRD42019120215. Results 8 studies were included: 4 (Paloma1/TRIO-18, Paloma2, Monaleesa2, Monarch3) investigated the role of CDK 4/6 inhibitors, 2 trials (SWOG and FACT) analysed the combination of Fulvestrant plus Aromatase Inhibitors, while other two trials explored the association of ET with Bevacizumab (LEA) and Temsirolimus (HORIZON), respectively. Overall, the meta-analysis showed a PFS advantage for the experimental arms [HR 0.77, p 0.016] with a significant high/moderate heterogeneity [I2 65.46%, p 0.005]. The 4 studies adding CDK4/6 inhibitors to ET showed a significant improvement in PFS compared to ET alone. No significant advantages for the addition of anti-angiogenic agents or Fulvestrant to ET have been found. Conclusions The novel experimental strategies showed an improvement in PFS in elderly patients. Adding CDK4/6 inhibitors to ET significantly prolongs PFS as compared to ET alone, the magnitude of PFS benefit is age-independent. To define the role of novel agents, future trials should be designed taking in account not only the age, but also adequate geriatric assessment and comorbidity status. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure L. Cortesi: Speaker Bureau / Expert testimony: Astazeneca; Speaker Bureau / Expert testimony: Pierre Fabre Pharma. F. Piacentini: Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: Pfizer. S. Cascinu: Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Lilly. L. Moscetti: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Roche; Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis. All other authors have declared no conflicts of interest.

Background Emerging literature data are showing that a change in human epidermal growth factor receptor (HER2) status adversely affects breast cancer patient's prognosis. The aim of this study was to evaluate the prognostic impact of HER2 loss in patients with HER2-positive disease treated with neoadjuvant therapy with or without anti-HER2 agents. Methods One hundred and seven consecutive HER2-positive patients were identified from a prospectively maintained database. The first cohort includes 40 patients treated with chemotherapy (CT) alone. The second cohort includes 67 patients treated with neoadjuvant CT plus anti-HER2 agents (trastuzumab and/or lapatinib). HER2 expression was evaluated by immunihistochemistry or fluorescence in situ hybridization on pretreatment core biopsy and on surgical specimen after therapy. Results The rates of pathologic complete response (pCR) and breast-conserving surgery were higher in the CT + anti-HER2 cohort. A loss of HER2 expression was observed in 40% of the patients with residual disease after CT alone versus 14.7% of the patients after CT + anti-HER2 agents (P = 0.019). Patients not achieving a pCR have a significant increase in the risk of relapse when compared with those achieving a pCR (hazard ratio [HR] 9.55, P = 0.028). Patients with HER2 loss tended to have a higher risk of relapse as comparing to patients with maintained HER2 positivity (HR 2.41, P = 0.063). Conclusion The pCR is confirmed as a powerful predictor of long-term outcome. The rate of HER2 loss is higher in patients receiving neoadjuvant CT without anti-HER2 agents. HER2 status on residual disease after preoperative therapy can be helpful in selecting patients at different risk of relapse, to be included in prospective trial exploring further adjuvant therapy.