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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

Phase 2
70 Years
Open (Enrolling)
Metastatic Breast Cancer, 70 Years Old Patients and Over, After One Line of Chemotherapy With Trastuzumab

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Trial Information

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

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 this population of patients show that the use of Capecitabine combined
with Lapatinib demonstrates an improvement of TTP without an increase of serious toxic

Our 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 (1250mg/day) and capecitabine (1st cycle day 1 to day 14: 850mg/m2/day x2; next
cycles day 1 to day 14: 1000 mg/m2/day x2) in term of clinical benefit, and with no adverse
effects and no detrimental impact on functional status (part of geriatric assessment).
Treatment will continue until disease progression or unacceptable toxicity occurence.

This is a phase II multicentric trial associated to a pharmacokinetic study which aims to
assess the effect of age modifications (absorption, distribution, metabolism and
elimination) on the combination Lapatinib-Capecitabine by measuring the Cmin-Cmax of both
components in elderly patients.

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

- Adequate hepatic function (total bilirubine ≤ 1.5ULN, ASAT and ALAT ≤ 3ULN)

- Adequate renal function (measured or calculated creatinine clearance ≥ 40 ml/min -

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy assessment

Outcome Description:

Benefit is defined as complete response, partial response, or stable disease according to RECIST criteria (vers. 1.1). Efficacy criteria is the number of patients meeting this definition. Patients having stopped before this 4-months time point will be considered as non responders without clinical benefit.

Outcome Time Frame:

at 4 months

Safety Issue:


Principal Investigator

Véronique GIRRE

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHD Vendée


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GERICO 09/0907



Start Date:

December 2009

Completion Date:

December 2014

Related Keywords:

  • Metastatic Breast Cancer
  • 70 Years Old Patients and Over
  • After One Line of Chemotherapy With Trastuzumab
  • Breast Neoplasms