Study in Elderly Patients With Early Breast Cancer (ICE)

Title of the study: Ibandronate with or without Capecitabine in Elderly Patients with Early Breast Cancer - (ICE Study) Rationale: Approximately 50% of new diagnosis of early breast cancer is made in patients above the age of 65. As this age group has not been eligible for most trials in the past, the effect of adjuvant therapy is still unclear in elderly patients. The primary aim of this trial will be to determine the role of adjuvant chemotherapy with capecitabine in elderly patients. The high activity, acceptable toxicity and oral formulation of this compound especially meet the requirements of elderly patients. Bisphosphonates are of established effectivity in treatment and prevention of osteoporosis. Furthermore, two studies have recently shown that adjuvant long term use of clodronate can reduce the risk of recurrence of breast cancer. The third generation bisphosphonate ibandronate will be given in this trial to all patients to prevent osteoporosis and recurrence from breast cancer, both conditions these patients are at risk. As the preference of elderly patients for intravenous or oral application is not known, the mode of application of ibandronate will be according to patients' choice and the preference and compliance will be a secondary endpoint. Primary objective To compare the event-free survival in elderly patients after local treatment for primary breast cancer treated with either ibandronate alone or ibandronate and capecitabine as adjuvant treatment Secondary objectives To compare the overall survival between the two arms To determine the compliance in both arms To determine the toxicity in both arms To determine the rate of bone-related events in hormone sensitive and insensitive disease (with or without endocrine therapy) To determine the preference to oral or intravenous application of ibandronate To assess quality of life To compare a geriatric assessment by Charlson versus VES 13 score Tertiary objective To determine prognostic factors on tumor tissue collected from primary surgery and to correlate them with study treatment effect To evaluate the prognostic impact of age, serum albumin, hemoglobin level, creatinine clearance, Charlson Score, VES-Score in a multivariate analysis for the prediction of treatment associated adverse events and limited life time expectancy