Ibandronate With or Without Capecitabine in Elderly Patients With Early Breast Cancer
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Any local or distant relapse of breast cancer, any second malignancy, and any death irrespective of its cause
Ulrike Nitz, MD
Principal Investigator
Evangelisches Krankenhaus Bethesda, Mönchengladbach
Germany: Federal Institute for Drugs and Medical Devices
GBG 32
NCT00196859
June 2004
August 2013
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