metastatic breast cancer patients MedDRA version: 9.1 Level: LLT Classification code 10057654 Term: Breast cancer female
Conditions
Interventions
Trade Name: CAELYX
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Doxorubicin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Metastati breast cancer (radiologic and hystologic evidence) Liver metastasis radiologically confirmed Cumulative dose of doxorubicin previously administered less or equal to 220 mg/m2 (360 mg/m2 for epirubicin) Evaluable disease following the WHO criteria Normal left ventricular function studied with a scintigraphy or an ecography Normal ECG and absence of clinical signs/syntomps of heart failure (NYHA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy or lactation Severe infectious or other disease (clinically relevant) Cerebral metastasis Previous or concurrent malignancy Hypersensitivity to antracyclines, cyclophosphamide or iodinate contrasts Previous treatment with weekly antracyclines, taxanes or other metronomic chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of a at least 2 months difference in time to progression between the proposed association and the standard regimen AC;Secondary Objective: Evaluation of the response rate and overall survival of the two regimens Evaluation of the clinical benefit (percentage of patients responding or stabilizing for at least 6 months) Study of the vascular and volumetric changes in neoplastic lesions with TC-NMR contrast-imaging;Primary end point(s): evaluation of a at least 2 months difference in time to progression between the proposed association and the standard regimen AC | — |
Countries
Italy
Outcome results
None listed