Adjuvant Capecitabine in Elderly Patients With Breast Cancer: a Phase II Study
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety of capecitabine in ederly
safety of capecitabine in ederly
1 year
Yes
Chantal Bernard, MD
Principal Investigator
Jules Bordet Institute
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Elderly capecitabine 1
NCT00263705
January 2003
August 2009
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