A PHASE II STUDY OF THE EFFECTIVENESS AND TOLERABILITY OF PEGYLATED LIPOSOMAL DOXORUBICIN IN ASSOCIATION WITH DAILY ORAL CYCLOPHOSPHAMIDE IN METASTATIC BREAST CANCER PATIENTS - I.C.E.-2007
- Conditions
- metastatic breast cancer patientsMedDRA version: 9.1Level: LLTClassification code 10057654Term: Breast cancer female
- Registration Number
- EUCTR2007-003278-24-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA SENESE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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 < 2)
Non evidence of present or pregress severe cardiovascular disease
Normal blood cell count
Normal epatic and renal function
Non evidence of secondary cancers
Basal ECOG 0 or 1
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>Evaluation of the clinical benefit (percentage of patients responding or stabilizing for at least 6 months)<br>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
- Secondary Outcome Measures
Name Time Method