EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly With advanCed breasT Cancer

Study Overview
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Brief Summary
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This is a randomized study evaluating the efficacy and impact on function of two different doses of nab-Paclitaxel in elderly patients with advanced breast cancer.

Detailed Description
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This open-label, randomized phase II trial evaluates in parallel two doses of nab-Paclitaxel (100 and 125mg/m2) given weekly for 3 weeks every 28 days, in elderly women aged 65 years or older, as first line treatment for advanced breast cancer (locally recurrent or metastatic). A short geriatric evaluation of co-morbidity and functional status will be performed before study entry. The functional status will be monitored at baseline and at every cycles during treatment.

Official Title
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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
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Breast Cancer

Intervention / Treatment
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* Drug: Nab-paclitaxel


Participation Criteria
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Eligibility Criteria
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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 ECOG performance status 0-2 Estimated life expectancy of ≥ 12 weeks No known active/symptomatic CNS metastases No previous chemotherapy for breast cancer in the advanced setting Adequate organ function including ( Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Bilirubin ≤ 1.5 mg/dL; ALT and AST ≤ 3 x ULN (with or without known hepatic metastases); ALP ≤ 2.5 x ULN; Serum creatinine ≤ 1.5 ULN or calculated creatinine clearance (CrCl) ≥ 50mL/min according to the Cockcroft Gault formula Written informed consent (according to ICH/GCP and national/local regulations) Exclusion Criteria: Significant peripheral neuropathy (significant peripheral neuropathy is defined as ≥ grade 2 on CTCAE v4.0 criteria) Clinically significant comorbidities including: uncontrolled cardiac arrhythmias (except 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 Other malignancy within the last 5 years, except for adequately treated non-melanomatous skin cancers, cervical intraepithelial neoplasia or cervical carcinoma in situ Intake of any concomitant medications or therapies that may potentially interact with the trial agent. Any prohibited medication must be discontinued at least 14 days prior to trial entry Presence of any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before trial registration

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm B<br>Nab-paclitaxel 125 mg/mq weekly for 3 out of every 4 weeks | Drug: Nab-paclitaxel<br>* comparison of different dosages of drug<br>* Other names: Abraxane;|
| Experimental: Arm A<br>Nab-paclitaxel 100 mg/mq weekly for 3 out of every 4 weeks | Drug: Nab-paclitaxel<br>* comparison of different dosages of drug<br>* Other names: Abraxane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival (EFS) | Event is defined as either disease progression or death, or functional decline. Functional decline is defined as decreased in at least 1 point from baseline ADL, and/or IADL, as confirmed by the investigator as treatment-related and confirmed at the subsequent cycle | Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Documentation of disease response or progression will be based on RECIST 1.1 criteria | Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient). | 
| Clinical benefit rate (CBR) | Documentation of disease response or progression will be based on RECIST 1.1 criteria | Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient) | 
| Progression free survival (PFS) | Documentation of disease progression will be based on RECIST 1.1 criteria | Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient) | 
| Overall survival (OS) | Documentation of death | Every 12 weeks until death or trial completion (12 months after randomization of the last patient) | 
| Incidence of adverse events | Severity will be reported based on CTCAE v4.0 | Every 12 weeks until event occurrence or trial completion (12 months after randomization of the last patient) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, elderly patients