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

Conditions: ocally advanced or metastatic breast cancer over expressing HER2 and = 70 years old
MedDRA version: 12.0Level: LLTClassification code 10055113Term: Breast cancer metastatic
MedDRA version: 12.0Level: LLTClassification code 10048406Term: Breast cancer aggravated

Registration Number: EUCTR2009-015981-73-FR

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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)
11.LVEF = 50% (US or isotopic method)
12.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)
13.Patients must be affiliated to a Social Security System
14.Patient information and written informed consent form signed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.