Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT01262469
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT01262469
Study Brief:
Protocol Section:
NCT01262469