Locally advanced inoperable or metastatic breast carcinoma MedDRA version: 6.1 Level: PT Classification code 10057654
Conditions
Interventions
Trade Name: ENDOXAN BAXTER 50MG 50CPR
Pharmaceutical Form: Tablet
INN or Proposed INN: Cyclophosphamide
CAS Number: 6055-19-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
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 No more than 3 previous lines of chemotherapy for advanced disease. 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 bevacizumab or other agents used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: this is a randomized phase II study, assessing the activity and tolerability of two different metronomic regimens, both in combination with bevacizumab patients in arm A will receive oral cyclophosphamide methotrexate in combination with intravenous bevacizumab, and patients in arm B will receive oral cyclophosphamide capecitabine in combination with intravenous bevacizumab. The main objective is to assess the activity of each regimen in terms of overall clinical benefit, defined as the objective response rate plus the rate of stable disease lasting longer than 24 weeks;Primary end point(s): The main objective is to assess the activity of each regimen 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: describe the toxicity and to estimate the time to disease progression and the overall survival in each treatment arm, as well as to evaluate the impact of treatment on tumor angiogenesis, assessing the changes in levels of circulating endothelial cells. and the changes in tumor perfusion measured by functional CT, with the two treatments. | — |
Countries
Italy
Outcome results
None listed