Triple negative metastatic breast cancer resistant secondary to anthracyclines and taxanes MedDRA version: 14.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: CISPLATIN
Product Name: CISPLATIN
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: CISPLATIN
Other descriptive name: CISPLATIN
Concentration unit
Sponsors
CENTRE JEAN PERRIN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 ans, Performance status 3 000/mm3, Hb > 9g/dL, Hepatic Functions : total Bilirubin = 1,5 time upper normal value (UNV), ASAT = 2 ,5 time UNV, ALAT = 2,5 time UNV, Alcaline Phosphatase = 2,5 time UNV ( 1,5 time UNV, so Clearance = 50 mL/min) or Clearance = 40 mL/min in case of RMI, Patient signed the consent study form, Patient affilated to a social security regimen (law of 9 August 2004). 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: Male Patients, Unknown hormonal Receptors Positive HER-2 (Score 3 in IHC or positive FISH) Pregnant or breastfeeding patient, or in age of pregnancy or predicting to be pregnant in the 6 months after the end of treatment, Patient not using contraceptive treatment during the treatment or after the 6 months after the end of treatment, Patient is a ward, Patient suffering from a non compatible disease with the enrollment in the study, Cardiac, renal, medullar, respiratory or hepatic insuffisancy, clinically significant cardiovascular disease (including myocardic infarctus, unstable angina, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia) grade 2, Antecedent of hypersensibility to one of study treatment or one of used excipients, Urinary tract infection or acute hemorrhagic cystitis in progress Concomitant treatment with a medicine containing phenytoin or medication received in the context of a trial, or participation in another therapeutic clinical trial within <30 days prior treatment with chemotherapy. Geographically unstable patient in the next 6 months or remaining distance to the treatment center making it difficult to follow in the study, Known history of abuse of narcotic or other drug or alcohol History of surgery within 28 days before the start of treatment, Patient unwilling or unable to comply with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate response rate of cisplatine - metronomic cyclophosphamide treatment;Secondary Objective: To evaluate disease free progression To determine safety profile of cisplatine - metronomic cyclophosphamide association To determine overall survival;Primary end point(s): To evaluate response rate of cisplatine - metronomic cyclophosphamide treatment;Timepoint(s) of evaluation of this end point: At the last visit of the last subject undergoing the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate disease free progression To determine safety profile of cisplatine - metronomic cyclophosphamide association To determine overall survival;Timepoint(s) of evaluation of this end point: At the last visit of the last subject undergoing the trial | — |
Countries
France
Contacts
Public ContactJEAN-MARC NABHOLTZ
CENTRE JEAN PERRIN
Outcome results
None listed