metastatised breast cancer, first line treatment Level: PT Classification code 10057654
Conditions
Interventions
Trade Name: HERCEPTIN
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: Trastuzumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
GOIM GRUPPO ONCOLOGICO MERIDIONALE
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: previous chemiotherapy for metastatic disease, concomitant serious diseases (cardiovascular, renal etc.), preesistent neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the antitumor activity of the combination of Gemcitabine and Docetaxel plus Trastuzumab in terms of objectives response;Secondary Objective: to estimate the toxicity (in particular the cardiotoxity), the duration of response, the time to progression and the overall survival;Primary end point(s): To estimate the antitumor activity of the combination of Gemcitabine and Docetaxel plus Trastuzumab in terms of objectives response | — |
Countries
Italy
Outcome results
None listed