EFFECT: A randomized phase II study to evaluate the EFficacy and impact on Function of two different doses of nab-paclitaxEl in elderly patients with advanCed breasT cancer

• Conditions: Patients aged 65 years or older with histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; HER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapy; Therapeutic area: Diseases [C] - Cancer [C04]; any estrogen/progesterone receptor status; MedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2012-002707-18-IT
• Lead Sponsor: FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI-ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-25
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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
oStaging 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

- active/symptomatic CNS metastases
- previous chemotherapy for breast cancer in the advanced setting

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and impact on functional status of two different doses of nab-paclitaxel;Secondary Objective: Secondary objectives<br>To evaluate the objective response rate (CR+PR) on the two nab-paclitaxel treatment arms<br>To evaluate the clinical benefit rate (CR+PR+SD) on the two nab-paclitaxel treatment arms<br>To evaluate the duration of progression-free survival and overall survival on the two nab-paclitaxel treatment arms<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): •Objective response rate (ORR)<br>•Clinical benefit rate (CBR)<br>•Progression free survival (PFS)<br>•Overall survival (OS)<br>•Incidence of Adverse events;Timepoint(s) of evaluation of this end point: 42 mesi