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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2009-015981-73-FR |
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Date of registration:
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23/10/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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08/12/2009 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015981-73 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Age = 70
2. Histological confirmed advanced breast cancer (metastatic or locally advanced)
3. Tumor over expressing HER2 (HER2 3+ in IHC or IHC 2+ and Fish positive) in sample from the primary and/or secondary tumor
4. WHO performance status (EGOG) from 0 to 2
5. MMS > 25
6. Measurable disease (RECIST criteria)
7. Progression of disease after one metastatic line of chemotherapy associated with trastuzumab (must be stopped at least 3 weeks before beginning the trial)
8. Adequate hematological function (Hb = 9g/dl, ANC = 1500/mm3, platelets = 100 000/mm3)
9. Adequate hepatic function (total bilirubine = 2.5 mg/dl, ASAT and ALAT = 3ULN)
10. Adequate renal function (measured or calculated creatinine clearance = 40 ml/min - Cockroft)
11. LVEF = 50% (US or isotopic method)
12. 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)
13. Patients must be affiliated to a Social Security System
14. Patient information and written informed consent form signed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Life expectancy < 3 months
2. Prior treatment with capecitabine or lapatinib
3. Concomitant radiotherapy except for palliative reason and more than 25% of the BM
4. Patients with pre-existing toxicity = grade 2 (excepted alopecia)
5. Patients with dysphagia, or inability to swallow the capsules.
6. 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
7. Patient already included in another therapeutic trial using an experimental drug within 30 days preceding entry into the study
8. Individual deprived of liberty or placed under the authority of a tutor
9. Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Locally advanced or metastatic breast cancer over expressing HER2 and = 70 years old
MedDRA version: 12.0
Level: LLT
Classification code 10055113
Term: Breast cancer metastatic
MedDRA version: 12.0
Level: LLT
Classification code 10048406
Term: Breast cancer aggravated
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Intervention(s)
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Trade Name: TYVERB
Pharmaceutical Form: Coated tablet
Trade Name: XELODA
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CAPECITABINE
CAS Number: 154361-50-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 850-
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Primary Outcome(s)
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Main Objective: 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).
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Primary end point(s): The trial is designed according to the Bryant and Day methodology, allowing the evaluation of both (1) therapeutic efficacy and (2) tolerance, this latter encompassing standard toxicity due to treatment (NCIC CTC v.4) and deleterious impact of treatment on functional status (IADL).
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Secondary Objective: - Duration of clinical benefit
- Time to progression defined as the time from inclusion to disease progression or death due to breast cancer
- Overall response rate
- Progression free survival (the time from inclusion to disease progression or death due to any cause)
- Overall survival
- Time to treatment failure
- Determination of toxicity of the combination
- Number of patients treated with 3 and 6 cycles and % of dose administrated
- Investigation of the minimal and maximal concentration (Cmin-Cmax) of lapatinib and capecitabine
- Geriatric impact of the combination on ADL, IADL, G8 (ONCODAGE) , QLQC30 item 29-30
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Secondary ID(s)
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GERICO 09/0907
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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