Patients aged 65 years or older with histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic
Conditions
Interventions
Trade Name: ABRAXANE*INF 100MG 5MG/ML
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg milligram(s)
Co
Sponsors
FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI-ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; any estrogen/progesterone receptor status; HER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapy (e.g. known congestive cardiac failure). • Measurable disease or non-measurable but evaluable disease according to RECIST 1.1 criteria (see Appendix B) [Eisenhauer] • Age = 65 years • Female • ECOG performance status 0-2 • Estimated life expectancy of = 12 weeks o Staging CT or MRI brain is required only if clinically indicated • Adequate organ function • No significant peripheral neuropathy (significant peripheral neuropathy is defined as = grade 2 on CTCAE v4.0 criteria) • No clinically significant comorbidities including: uncontrolled cardiac arrhythmias (with the exception of rate-controlled atrial fibrillation), NYHA class III or IV cardiac failure, uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity • No other malignancy within the last 5 years, with the exception of adequately treated non-melanomatous skin cancers, cervical intraepithelial neoplasia or cervical carcinoma in situ • No requirements for concomitant medications or therapies that may potential interact with the trial agent. Any prohibited medication must be discontinued at least 14 days prior to trial entry • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Are the trial subjects under 18? no Number of subjects for this age range: 0 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 156
Exclusion criteria
Exclusion criteria: - active/symptomatic CNS metastases - previous chemotherapy for breast cancer in the advanced setting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and impact on functional status of two different doses of nab-paclitaxel;Secondary Objective: Secondary objectives To evaluate the objective response rate (CR+PR) on the two nab-paclitaxel treatment arms To evaluate the clinical benefit rate (CR+PR+SD) on the two nab-paclitaxel treatment arms To evaluate the duration of progression-free survival and overall survival on the two nab-paclitaxel treatment arms To evaluate the safety and tolerability for the two dosing regimens;Primary end point(s): Event-free survival (EFS) where an event is either disease progression or death or decline in functional status;Timepoint(s) of evaluation of this end point: 42 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Objective response rate (ORR) • Clinical benefit rate (CBR) • Progression free survival (PFS) • Overall survival (OS) • Incidence of Adverse events;Timepoint(s) of evaluation of this end point: 42 mesi | — |
Countries
Italy
Contacts
Public ContactOncologia Medica
Azienda USL 4 Prato
Outcome results
None listed