early breast cancer in elderly patients or patients who are unfit for a polychemotherapy regimen MedDRA version: 16.0 Level: LLT Classification code 10006190 Term: Breast cancer invasive NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ABRAXANE
Pharmaceutical Form:
Trade Name: Epirubicina
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Women 65 years of age or older, Performance status (ECOG) 0-2, Charlson Scale = 2, or Women 64 years or younger, who SHOULD receive an adjuvant chemotherapy according to the 2011 St Gallen Guidelines but who are NOT candidates to a 3-weekly taxane- and anthracycline-based regimen, Performance status (ECOG) 0-2 , Charlson Scale = 2 ? Operable, histologically confirmed adenocarcinoma of the breast ? Tumor diameter > 1 cm ? The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere. ? Patients with synchronous (diagnosed histologically within 2 months) bilateral invasive breast cancer are eligible if all other criteria are met. ? Patients must have had surgery for primary breast cancer with no known clinical residual loco-regional disease. ? Margins must be negative for invasive breast cancer and DCIS. ? Patients should be randomized and start treatment as close to definitive surgery as possible; within 6 weeks is recommended and not more than 12 weeks (from last surgery in case of bilateral breast cancer). 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 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: ? Patients with locally advanced inoperable breast cancer including inflammatory breast cancer, supraclavicular node involvement, or enlarged internal mammary nodes (unless pathologically negative). ? Patients with a history of any prior ipsilateral or contralateral invasive breast cancer. ? Patients with previous or concomitant malignancy diagnosed within the past five years. Patients with adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma are eligible regardless of the date of diagnosis. ? 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 myocardial infarction, pulmonary embolism or deep venous thrombosis within 6 months prior to randomization. ? Patients with at least one of the so-called “geriatric syndromes”: dementia, delirium, major depression (as diagnosed by a psychiatrist), recent falls, spontaneous bone fractures, neglect, and abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Disease Free Survival;Secondary Objective: •To evaluate Physical function using the Vulnerable Elders Survey (VES-13). •To describe cognitive function by using the Mini-Cog •To evaluate Fatigue by using the Brief Fatigue Inventory (BFI) . •To compare the Charlson Index versus the Cumulative Illness Rating Scale (CIRS) in all patients. •Breast cancer free interval (BCFI) •Overall survival (OS) ;Primary end point(s): Disease Free Survival ;Timepoint(s) of evaluation of this end point: monthly during treatment (first 4 months), then every 6 months up to 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adverse events - Tolerability - Patient-rated Quality of Life (QL) assessments (Global Quality of Life form (GQL) and Symptom Specific QL form, SSQL);Timepoint(s) of evaluation of this end point: monthly during treatment (first 4 months), then every 6 months up to 5 years | — |
Countries
Italy
Contacts
Public ContactUFFICIO STUDI CLINICI
ISTITUTO EUROPEO DI ONCOLOGIA
Outcome results
None listed