CLINICAL ACTIVITY OF DNA DAMAGING AND NON-DAMAGING CHEMIOTHERAPY REGIMENS IN ADVANCED BREAST CANCER PATIENTS WITH DIFFERENT BIOLOGICAL SUB-TYPES DEFINED BY BIOMARKERS EVALUATION ON CIRCULATING TUMOR CELLS - CTC PLATINUM

Conditions: METASTATIC BREAST CANCER
MedDRA version: 9.1Level: SOCClassification code 10038604

Registration Number: EUCTR2009-012738-65-IT

Lead Sponsor: AZIENDA USL 4 PRATO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

ADVANCED BREAST CANCER PATIENTS WHO HAD PROGRESSED ON PRIOR REGIMENS CONTAINING AN ANTRACYCLINE AND/OR TAXANE BASED THERAPY; PATIENTS WITH ECOG PERFORMANCE STATUS OF 0 TO 2; MEASURABLE DISEASE ACCORDING TO RECIST CRITERIA; RENAL, LIVER AND HEMOPOIETIC FUNCTION IN THE LIMITS; PRESENCE OF CTCs IN PERIPHERAL BLOOD SAMPLE; WRITTEN INFORMED CONSENT
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

PRESENCE OF RILEVANT CO-MORBIDITIES; PREGNANT OR LACTATING WOMEN; ALTERED MENTAL STATUS; CONCURRENT ANTI-CANCER THERAPIES OTHER THAN STUDY DRUGS

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: TO DEMONSTRATE THAT IN THE COHORT OF CARRYNG CTC WITH A BASAL-LIKE PHENOTYPE OBJECTIVE RESPONSE RATES TO THE DNA DAMAGING AND TO THE DNA NON-DAMAGING REGIMENS WILL BE 70% AND 20% RESPECTIVELY.;Secondary Objective: TO EVALUATE THE LEVEL OF CONCORDANCE IN TERMS OF BREAST CANCER MOLECULAR SUBTYPE DEFINITION BETWEEN THE PRIMARY TUMOR, CORRESPONDING CTCs AND METASTATIC SITES; TO CORRELATE TIME TO PROGRESSION AND OVERALL SURVIVAL WITH THE MOLECULAR SUBTYPE AVALUATED ON CTCs;Primary end point(s): TIME TO PROGRESSION AND OVERALL SURVIVA

Secondary Outcome Measures