Evaluating Lapatinib + Capecitabine in Patients Aged 70 and Over With HER2 Metastatic Breast Cancer.
NCT ID: NCT01262469
Last Updated: 2014-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
4 participants
INTERVENTIONAL
2009-12-31
2013-11-30
Brief Summary
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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).
Detailed Description
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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 effects.
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lapatinib + Capecitabine
lapatinib 1250 mg/day (once daily) Capecitabine 2x850 mg/m2/day, days 1-14 during the first cycle and 2x1000 mg/m2/day, days 1-14, every 21 days for following cycles ( if no unacceptable toxicity is observed).
lapatinib + capecitabine
For Lapatinib: 5 tablets of 250 mg each, once daily, until disease progression or unacceptable toxicity occurence.
For Capecitabine: 850 mg/m2 twice a day from day 1 to 14 of cycle 1 and 1000 mg/m2 twice a day from day 1 to 14 of the next cycles.
Interventions
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lapatinib + capecitabine
For Lapatinib: 5 tablets of 250 mg each, once daily, until disease progression or unacceptable toxicity occurence.
For Capecitabine: 850 mg/m2 twice a day from day 1 to 14 of cycle 1 and 1000 mg/m2 twice a day from day 1 to 14 of the next cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
70 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Véronique GIRRE
Role: PRINCIPAL_INVESTIGATOR
CHD Vendée
Locations
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Centre Paul Papin
Angers, , France
Centre Hospitalier de Beauvais
Beauvais, , France
Clinique Tivoli
Bordeaux, , France
Ch Fleyriat
Bourg-en-Bresse, , France
Institut Cancérologie- CENTRE HOSPITALIER BREST
Brest, , France
Centre Francois Baclesse
Caen, , France
Centre Hospitalier de Lagny-Sur-Marne
Lagny-sur-Marne, , France
Centre Oscar Lambret
Lille, , France
Institut Paoli Calmettes
Marseille, , France
Centre Rene Gauducheau
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Centre Hospitalier Orleans La Source
Orléans, , France
Institut Curie
Paris, , France
Hegp-Hopital Broussais
Paris, , France
Polyclinique de Courlancy
Reims, , France
Centre Hospitalier de Roanne
Roanne, , France
Centre Henri Becquerel
Rouen, , France
Centre Rene Huguenin
Saint-Cloud, , France
Centre Paul Strauss
Strasbourg, , France
Institut Claudius Regaud
Toulouse, , France
Countries
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Other Identifiers
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2009-015981-73
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GERICO 09/0907
Identifier Type: -
Identifier Source: org_study_id