AzTrials
AzTrials

Metastatic Breast CancerPhase 2GERICO09NCT01262469

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

A Phase 2 study testing lapatinib + capecitabine in people with Metastatic Breast Cancer and 70 Years Old Patients and Over, run by UNICANCER at 20 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
lapatinib + capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
20 sitesFrance
Study dates
Dec 2009to Nov 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • Centre Paul Papin

    Angers, 49933

  • Centre Hospitalier de Beauvais

    Beauvais, 60021

  • Clinique Tivoli

    Bordeaux, 33000

  • Ch Fleyriat

    Bourg-en-Bresse, 01012

  • Institut Cancérologie- CENTRE HOSPITALIER BREST

    Brest, 29200

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Hospitalier de Lagny-Sur-Marne

    Lagny-sur-Marne, 77405

  • Centre Oscar Lambret

    Lille, 59020

  • Institut Paoli Calmettes

    Marseille, 13273

  • Centre Rene Gauducheau

    Nantes, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • Centre Hospitalier Orleans La Source

    Orléans, 45100

  • Institut Curie

    Paris, 75005

  • Hegp-Hopital Broussais

    Paris, 75015

  • Polyclinique de Courlancy

    Reims, 51100

  • Centre Hospitalier de Roanne

    Roanne, 42328

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Centre Paul Strauss

    Strasbourg, 67065

  • Institut Claudius Regaud

    Toulouse, 31052

Other trials in France

About this study

Official title: 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

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.

Read more

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).

Read the detailed description

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 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.

Being tested
lapatinib + capecitabine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lapatinib + capecitabineDrug

    Also called Tyverb, Xeloda

    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.

Study groups in NCT01262469
Study groupRoleWhat they receive
Lapatinib + CapecitabineExperimentallapatinib 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).
Receives: Drug: lapatinib + capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy assessment

    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.

    Measured: at 4 months

  2. Tolerance criteria and impact on functional status

    The criteria is the number of patients for whom a toxicity event (according to the NCI-CTC AE vers.4)and/or an impact on functional status (defined by the 8 items IADL assessment scale) has been observed during the first 4 months of treatment.

    Measured: at 4 months

Secondary outcomes (10)

  1. Duration of clinical benefit

    Measured: from treatment start until disease progression

  2. Time to progression

    Measured: from inclusion to disease progression or death due to breast cancer

  3. Overall response rate

    Measured: from treatment start until end of treatment

  4. Progression free survival

    Measured: from inclusion to disease progression or death due to any cause

  5. Overall survival

    Measured: from inclusion until death due to any cause or last follow-up news (censored data)

  6. Time to treatment failure endpoint

    Treatment stop can be due to toxicity, death, refusal to continue study, or progressive disease.

    Measured: from inclusion to end of treatment

  7. Determination of toxicity of the combination (NCI-CTC vers.4)

    Measured: from informed consent signature to one month after last study drug intake

  8. Geriatric Evaluation

    Activities of daily Living (ADL)/ Instrumental ADL(IADL), Geriatric depression scale (GDS), Mini Mental States (MMS), comorbidities (CIRGS), G8 (oncodage), Vulnerable Elders Survey (VES13), QLQC30 item 29-30.

    Measured: At baseline, at uneven cycles, at end of treatment and at follow-up visits (every 6 months)

  9. Determination of the minimal and maximal concentration of lapatinib and capecitabine

    The samples time points are the followings:

    T0 : before administration of treatment (lapatinib is administered 1 hour before meal and capecitabine 30 min before meal)

    T1 : time for Cmax (2 hrs post-dose lapatinib and 90 min post-dose of capecitabine)

    Measured: at Day1 Cycle1 and Day1 Cycle3

  10. Number of patients treated with 3 and 6 cycles and % of dose administrated

    Measured: From treatment start until 6 cycles of treament

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionDec 2011
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01262469
Sponsor's protocol ID
GERICO 09/0907
Other IDs
2009-015981-73, 2009
Acronym
GERICO09
Status last verified
Dec 2014
First submitted
16 Dec 2010
Last updated
16 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lapatinib + capecitabine in people with Metastatic Breast Cancer and 70 Years Old Patients and Over, run by UNICANCER at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy assessment (time frame: at 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01262469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in