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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: |
EUCTR2006-005000-13-IT |
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Date of registration:
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12/06/2007 |
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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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Randomized Phase II trial with cetuximab and cisplatin in the treatment of ER-negative, PgRnegative, HER2-negative metastatic breast carcinoma (?basal-like?) - ND
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Scientific title:
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Randomized Phase II trial with cetuximab and cisplatin in the treatment of ER-negative, PgRnegative, HER2-negative metastatic breast carcinoma (?basal-like?) - ND |
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Date of first enrolment:
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09/07/2007 |
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Target sample size:
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180 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005000-13 |
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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: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Cisplatino
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Phase:
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Countries of recruitment
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Austria
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Germany
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Ireland
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Italy
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Portugal
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Spain
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Female inpatient/outpatient >=18 years of age ? Histologically confirmed diagnosis of metastatic breast cancer (Stage IV). Estrogen receptor (ER)-negative, progesterone receptor (PgR)-negative and HER2 <3+ expression by immunohistochemistry (IHC) (fluorescence in situ hybridization [FISH] test negative if 1+ or 2+ by IHC) (this confirmatory test should be performed when possible) ? No more than one prior chemotherapy regimen received for treating this metastatic breast cancer ? No more than one prior anthracycline and/or taxane regimen (either adjuvant or metastatic setting) ? At least one measurable lesion by CT or MRI according to RECIST ? Signed written informed consents prior to starting any study investigation ? Tumor tissue available for EGFR expression assessment and exploratory biomarker analysis ? Eastern Cooperative Oncology Group (ECOG) PS 0-2 and life expectancy of at least 6 months at study entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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:
Prior platinum agent ? Prior mitomycin ? Known history of brain metastases ? Previous or current malignancy except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix ? Previous exposure to monoclonal antibody therapy, signal transduction inhibitors or EGFR-targeting therapy ? Any investigational medication within 30 days before study entry.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Metastatic Breast Cancer (Stage IV) "basal like".
MedDRA version: 9.1
Level: LLT
Classification code 10006279
Term: Breast neoplasm
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Intervention(s)
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Trade Name: Cetuximab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: cisplatino
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
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Primary Outcome(s)
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Main Objective: To assess overall response to cetuximab in combination with cisplatin and to show the superiority of the combination over cisplatin alone, in subjects with ?triple negative? metastatic breast cancer.
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Primary end point(s): Best overall response according to RECIST definitions
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Secondary Objective: To compare the differences between the 2 treatment groups using: progression-free survival (PFS), overall survival (OS), time to response and safety. To investigate downstream effects on biomarkers and population pharmacokinetics.
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Secondary ID(s)
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2006-005000-13-IE
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EMR 200027-051 (BALI-1)
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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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