PHASE II STUDY Evaluating the Toxicity and Activity of the Combination Lapatinib + Capecitabine in Elderly Patients Aged 70 and Over With Metastatic Breast Cancer Over Expressing HER2
More than half of patients who have breast cancer with Her2-positive tumors treated with
trastuzumab as a single agent develop resistance within one year of treatment initiation.
Recent studies on this population of patients show that the use of Capecitabine combined
with Lapatinib demonstrates an improvement of TTP without an increase of serious toxic
Our study is designed to investigate whether elderly patients with locally advanced or
metastatic breast cancer over-expressing HER2 could take advantage of the combination
lapatinib (1250mg/day) and capecitabine (1st cycle day 1 to day 14: 850mg/m2/day x2; next
cycles day 1 to day 14: 1000 mg/m2/day x2) in term of clinical benefit, and with no adverse
effects and no detrimental impact on functional status (part of geriatric assessment).
Treatment will continue until disease progression or unacceptable toxicity occurence.
This is a phase II multicentric trial associated to a pharmacokinetic study which aims to
assess the effect of age modifications (absorption, distribution, metabolism and
elimination) on the combination Lapatinib-Capecitabine by measuring the Cmin-Cmax of both
components in elderly patients.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Benefit is defined as complete response, partial response, or stable disease according to RECIST criteria (vers. 1.1). Efficacy criteria is the number of patients meeting this definition. Patients having stopped before this 4-months time point will be considered as non responders without clinical benefit.
at 4 months
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)