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

FNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer)0 sitesOctober 23, 2009

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ocally advanced or metastatic breast cancer over expressing HER2 and = 70 years old
Sponsor: FNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer)
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

October 23, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

FNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer)

•1\.Age \= 70
•2\.Histological confirmed advanced breast cancer (metastatic or locally advanced)
•3\.Tumor over expressing HER2 (HER2 3\+ in IHC or IHC 2\+ and Fish positive) in sample from the primary and/or secondary tumor
•4\.WHO performance status (EGOG) from 0 to 2
•5\.MMS \> 25
•6\.Measurable disease (RECIST criteria)
•7\.Progression of disease after one metastatic line of chemotherapy associated with trastuzumab (must be stopped at least 3 weeks before beginning the trial)
•8\.Adequate hematological function (Hb \= 9g/dl, ANC \= 1500/mm3, platelets \= 100 000/mm3\)
•9\.Adequate hepatic function (total bilirubine \= 2\.5 mg/dl, ASAT and ALAT \= 3ULN)
•10\.Adequate renal function (measured or calculated creatinine clearance \= 40 ml/min \- Cockroft)

•1\.Life expectancy \< 3 months
•2\. Prior treatment with capecitabine or lapatinib
•3\. Concomitant radiotherapy except for palliative reason and more than 25% of the BM
•4\. Patients with pre\-existing toxicity \= grade 2 (excepted alopecia)
•5\. Patients with dysphagia, or inability to swallow the capsules.
•6\. Patient with malabsorption syndrome or disease significantly affecting gastro\-intestinal function or with major resection of stomach or proximal bowel that could affect absorption of oral drugs
•7\.Patient already included in another therapeutic trial using an experimental drug within 30 days preceding entry into the study
•8\.Individual deprived of liberty or placed under the authority of a tutor
•9\.Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule.