Locally advanced breast cancer MedDRA version: 6.1 Level: PT Classification code 10057654
Conditions
Interventions
Trade Name: CAELYX IV 1 FL 25 ML 2 MG/ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Doxorubicin
CAS Number: 25316-40-9
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women aged 66 years or older with histologically proven T2-4a-d, N0-3 any ER and PgR breast cancer. Patients not candidates to more intensive chemotherapy regimen according to clinician judgement . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV. Patients with at least one of the so-called geriatric syndromes dementia, delirium, major depression. Patients with a history of any prior ipsilateral or contralateral invasive breast cancer. Prior neoadjuvant or adjuvant therapy for breast cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the activity of PLD in a population of elderly patients aged 66 and older with locally advanced breast cancer who are not suitable to receive a standard anthracycline containing regimen.;Secondary Objective: a to assess the tolerability of PLD in an homogeneous population of naive elderly patients. b to assess the impact of treatment on quality of life QL and on physical functioning;Primary end point(s): a Clinical response rate complete and partial b Pathological complete remission pCR | — |
Countries
Italy
Outcome results
None listed