Adjuvant Capecitabine in Elderly Patients With Breast Cancer: a Phase II Study
Drug: Adjuvant capecitabine
Drug: capecitabine in aduvant setting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adjuvant Capecitabine in Elderly Patients With Breast Cancer: a Phase II Study|
- safety of capecitabine in ederly [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]safety of capecitabine in ederly
|Study Start Date:||January 2003|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
capecitabine 2000 mg/m² daily
Drug: Adjuvant capecitabine
Capecitabine 2000 mg/m² daily six cycles
Other Name: XelodaDrug: capecitabine in aduvant setting
capecitabine in aduvant setting in ederly with breast cancer
Other Name: Xeloda
Patients over 70 years old are under represented in clinical trials and there are no clear guidelines regarding the use of adjuvant chemotherapy for early breast cancer in this population. Whether CT retains the benefit conferred to younger patients remains uncertain. Moreover, there is extensive data regarding the increasing incidence and severity of side effects, such as myelotoxicity, mucositis and cardiotoxicity, with CT in this population. The efficacy and safety of CT in aged patients have been evaluated in different studies, most of them in haematological malignancy. Clearly, the patients' functional declines with age and the risk for CT toxicity rises with age. There is no standard of care regarding adjuvant chemotherapy for breast cancer in patients older than 70 years old.
This is a pilot study evaluating the feasibility and safety of 6 cycles of capecitabine in patients aged 70 years or more with high-risk early invasive breast cancer who have undergone optimal surgery.
The primary end point is to evaluate the possibility of delivering 6 cycles of capecitabine at the dose of 1000 mg/m² BID days 1 to 14 every 3 weeks, in terms of rate of patients who will receive an acceptable relative dose intensity (RDI).
Secondary end points are safety (including the evaluation of possible impact of treatment on the functional, cognitive and emotional status of the patient) and evaluating if some form of geriatric assessment add any information to the classic "inclusion criteria screening" in terms of prediction of treatment compliance and toxicity.
The study is being conducted at the Jules Bordet Institute. The planned accrual is 43 patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263705
|Jules Bordet Institute|
|Brussels, Belgium, 1000|
|Principal Investigator:||Chantal Bernard, MD||Jules Bordet Institute|