Study in Elderly Patients With Early Breast Cancer (ICE)

Breast Cancer Clinical Trial

Official title: Ibandronate With or Without Capecitabine in Elderly Patients With Early Breast Cancer

Status Completed

Clinical Trial Summary

This trial is done to determine the role of adjuvant chemotherapy with capecitabine in patients ≥ 65.

Clinical Trial Description

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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00196859
• Study type: Interventional
• Source: German Breast Group
• Status: Completed
• Phase: Phase 3
• Start date: June 2004
• Completion date: January 2014