METASTATIC BREAST CANCER (MBC) MedDRA version: 20.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AZIENDA SANITARIA OSPEDALIERA S.CROCE E CARLE CUNEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hystologically confirmed MBC Metastatic disease previously treated with at least two or three lines of systemic therapy or progressed during or within three months from the last chemotherapy regimen Measurable disease (RECIST criteria version 1.1). At least one metastatic site suitable for irradiation. Signed informed consent. Geographical accessibility. Age = 18 y.o. Karnofsky P.S. = 60 Life expectancy > 3 months. Adequate bone marrow function (Absolut Neutrophil count ¿ =¿1,5 x 109/l, platelets ¿ =¿100 x 109/l, hemoglobin ¿ =¿10 g/dL). Adequate liver function: transaminases = 2.5 x upper limit of normality (ULN); bilirubin = 1.5 x ULN. Adequate renal function: Creatinine = ULN or creatinine clearance > 60 mL/min (Cockroft-Gault). Adequate contraception for childbearing potential women. Adequate cardiac function (LVEF ¿ 50% evaluated by MUGA Scan or Echocardiography and electrocardiogram) 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Prior malignancies Prior organ transplantation Brain metastasis Autoimmune or allergic disorders Previous HBV and/or HCV infections Previous IL-2 treatment Active steroid therapy Any active infection requiring specific treatment (Antibiotics, antimicotic, antiviral) Radiotherapy within 6 weeks before enrollment. Pregnant or lactating females. Other non-malignant uncontrolled systemic diseases or social conditions that would preclude trial entry in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective response rate;Secondary Objective: Toxicity QoL Progression Free Survival Overall Survival ;Primary end point(s): Objective response rate;Timepoint(s) of evaluation of this end point: during treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Toxicity; QoL; Progression Free Survival; Overall Survival;Timepoint(s) of evaluation of this end point: DURING TREATMENT AND DURING 4 WEEKS AFTER END OF TREATMENT; EVERY CYCLE AND END OF TREATMENT; from study entry to first documented disease progression or death from any cause whichever occurred first; from study entry to death from any cause | — |
Countries
Italy
Contacts
Public ContactUFFICIO SPERIMENTAZIONI CLINICHE
AZIENDA OSPEDALIERA S. CROCE E CARLE DI CUNEO
Outcome results
None listed