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Trastuzumab, docetaxel and gemcitabine as first line treatment for HER-2 positive advanced breast cancer: a phase II of G.O.I.M. - ND

Conditions
metastatised breast cancer, first line treatment
Level: PTClassification code 10057654
Registration Number
EUCTR2007-003156-11-IT
Lead Sponsor
GOIM GRUPPO ONCOLOGICO MERIDIONALE
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

histologically confirmed metastatic breast cancer, tumor overexpressing HER2/neu (+++)or with HER2/neu
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

previous chemiotherapy for metastatic disease, concomitant serious diseases (cardiovascular, renal etc.), preesistent neuropathy

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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