Status:
COMPLETED
Evaluating Lapatinib + Capecitabine in Patients Aged 70 and Over With HER2 Metastatic Breast Cancer.
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Metastatic Breast Cancer
70 Years Old Patients and Over
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
GERICO 09/0907 is a Phase II multicentric trial evaluating the toxicity and activity of the combination of lapatinib and capecitabine in locally advanced or metastatic breast cancer over expressing HE...
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- Age ≥ 70
- Histological confirmed advanced breast cancer (metastatic or locally advanced)
- Tumor over expressing HER2 (HER2 3+ in IHC or IHC 2+ and Fish positive) in sample from the primary and/or secondary tumor
- WHO performance status (EGOG) from 0 to 2
- MMS \> 25
- Measurable disease (RECIST criteria)
- Progression of disease after one metastatic line of chemotherapy associated with trastuzumab (must be stopped at least 3 weeks before beginning the trial)
- Adequate hematological function (Hb ≥ 10g/dl, ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3)
- Adequate hepatic function (total bilirubine ≤ 1.5ULN, ASAT and ALAT ≤ 3ULN)
- Adequate renal function (measured or calculated creatinine clearance ≥ 40 ml/min - Cockroft)
- LVEF ≥ 50% (US or isotopic method)
- Absence of treatment by enzymatic inhibitors or inducers or any gastric pH modifying agent/drug within a 7-to-14 day period preceding the first administration of one of the trial's products and within the overall duration of the study (see medication list)
- Patients must be affiliated to a Social Security System
- Patient information and written informed consent form signed
Exclusion
- Life expectancy \< 3 months
- Prior treatment with capecitabine or lapatinib
- Concomitant radiotherapy except for palliative reason and more than 25% of the BM
- Patients with pre-existing toxicity ≥ grade 2 (excepted alopecia)
- Patients with dysphagia, or inability to swallow the capsules.
- 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
- Patient already included in another therapeutic trial using an experimental drug within 30 days preceding entry into the study
- Individual deprived of liberty or placed under the authority of a tutor
- Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01262469
Start Date
December 1 2009
End Date
November 1 2013
Last Update
December 16 2014
Active Locations (20)
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1
Centre Paul Papin
Angers, France, 49933
2
Centre Hospitalier de Beauvais
Beauvais, France, 60021
3
Clinique Tivoli
Bordeaux, France, 33000
4
Ch Fleyriat
Bourg-en-Bresse, France, 01012