Locally advanced or metastatic breast cancer over expressing HER2 and = 70 years old MedDRA version: 12.0 Level: LLT Classification code 10055113 Term: Breast cancer metastatic MedDRA version: 12.0 Level: LLT Classification code 10048406 Term: Breast cancer aggravated
Conditions
Interventions
Trade Name: TYVERB
Pharmaceutical Form: Coated tablet
Trade Name: XELODA
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CAPECITABINE
CAS Number: 154361-50-9
Concentration unit: mg milligram(
Sponsors
FNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess clinical benefit (defined at 4 months as complete response, partial response or stable disease), safety and preserved geriatric independence. (main objective is a “bi-criteria” or composite criteria).;Secondary Objective: - Duration of clinical benefit - Time to progression defined as the time from inclusion to disease progression or death due to breast cancer - Overall response rate - Progression free survival (the time from inclusion to disease progression or death due to any cause) - Overall survival - Time to treatment failure - Determination of toxicity of the combination - Number of patients treated with 3 and 6 cycles and % of dose administrated - Investigation of the minimal and maximal concentration (Cmin-Cmax) of lapatinib and capecitabine - Geriatric impact of the combination on ADL, IADL, G8 (ONCODAGE) , QLQC30 item 29-30;Primary end point(s): The trial is designed according to the Bryant and Day methodology, allowing the evaluation of both (1) therapeutic efficacy and (2) tolerance, this latter encompassing standard toxicity due to treatment (NCIC CTC v.4) and deleterious impact of treatment on functional status (IADL). | — |
Countries
France
Outcome results
None listed