advanced or metastatic breast cancer MedDRA version: 14.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ENDOXAN BAXTER*50CPR RIV 50MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Cyclophosphamide
Concentration unit: mg milligram(s)
Concentration number: 50-
Trade Name: XELODA*120
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. Immunohistochemical receptor status at the last biopsy available: ER and PgR absent (0% of the cells) or ER or PgR Absent or ER and PgR ≤ 50% of the cells Measurable disease Age >18 years Life expectancy of greater than 6 months. Are the trial subjects under 18? no Number of subjects for this age range: 0 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: Previous treatment with bevacizumab, EGFR inhibitors or metronomic cyclophosphamide + capecitabine. Immunohistochemical receptor status at the last biopsy available: ER and PgR≥50% Presence of cerebral or leptomeningeal involvement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the activity of the proposed regimen;Secondary Objective: ? To describe the toxicity of the regimen. ? To estimate the time to disease progression and the overall survival and rate of stable disease lasting longer than 24 weeks;Primary end point(s): overall clinical benefit, defined as the objective response rate plus the rate of stable disease lasting longer than 9 weeks. | — |
Countries
Italy
Outcome results
None listed