METASTATIC BREAST CANCER MedDRA version: 9.1 Level: SOC Classification code 10038604
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Pharmace
Sponsors
AZIENDA USL 4 PRATO
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: PRESENCE OF RILEVANT CO-MORBIDITIES; PREGNANT OR LACTATING WOMEN; ALTERED MENTAL STATUS; CONCURRENT ANTI-CANCER THERAPIES OTHER THAN STUDY DRUGS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 SURVIVAL | — |
Countries
Italy
Outcome results
None listed