Evaluating Lapatinib + Capecitabine in Patients Aged 70 and Over With HER2 Metastatic Breast Cancer.

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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 HER2 for patients aged ≥ 70 who have failed after one line of chemotherapy in combination with trastuzumab.

Due to the minimal participation of older people in clinical trials, there is a lack of data to make evidence-based decisions regarding chemotherapy in this indication.

The study is designed to investigate whether elderly patients with locally advanced or metastatic breast cancer over-expressing HER2 could take advantage of the combination lapatinib and capecitabine in term of clinical benefit, and with no adverse effects and no detrimental impact on functional status (part of geriatric assessment).

The main objective is 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Collaborator: GlaxoSmithKline
• Treatments: Capecitabine; Lapatinib

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.