Pre-or post-menopausal women with histologically proven, locally advanced (inoperable) or metastatic breast cancer.
Conditions
Interventions
Trade Name: HERCEPTIN
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Trastuzumab
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 4-
Tra
Sponsors
GOIM GRUPPO ONCOLOGICO MERIDIONALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pre- or post-menopausal women with histologically proven, locally advanced (inoperable) or metastatic breast carcinoma. Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. No previous lines of chemotherapy for advanced disease (primary and/or adjuvant chemotherapy are allowed, as well as any prior endocrine treatment; prior primary and/or adjuvant trastuzumab therapy are allowed, if ended  6 months before. At least 4 weeks must have elapsed since prior chemotherapy or radiation therapy, 6 weeks if the last regimen included mitomycin C). Age >18 years and 60% Normal organ and marrow function Ability to understand and the willingness to sign a written informed consent document 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
Exclusion criteria: Presence of cerebral or leptomeningeal involvement. Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix. History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab or other agents used in the study Seriuos cardiac illness -Poorly controlled hypertension Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, renal failure, or psychiatric illness/social situations that would limit compliance with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the activity in terms of overall clinical benefit, defined as the objective response rate plus the rate of stable disease lasting longer than 24 weeks.;Secondary Objective: To describe the toxicity and to estimate the time to disease progression and the overall survival, as well as to evaluate the impact of treatment on tumor angiogenesis, assessing the change in levels of circulating endothelial cells.;Primary end point(s): To assess the activity in terms of overall clinical benefit, defined as the objective response rate plus the rate of stable disease lasting longer than 24 weeks. | — |
Countries
Italy
Outcome results
None listed