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

January 9, 2018 updated by: Fondazione Sandro Pitigliani

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, 60100
        • A.O.U. Ospedali Riuniti
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Brescia, Italy, 25125
        • Spedali Civili Brescia
      • Brindisi, Italy, 72100
        • Ospedale Antonio Perrino
      • Frosinone, Italy, 09039
        • Ospedale SS. Trinita'
      • Lecce, Italy, 73100
        • Ospedale Vito Fazzi
      • Lucca, Italy, 50053
        • Ausl 12 Viareggio
      • Milano, Italy, 20141
        • Istituto Europeo Oncologia
      • Napoli, Italy, 80131
        • A.O.U. Federico Ii Di Napoli
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto
      • Pavia, Italy, 27100
        • Fondazione Maugeri
      • Udine, Italy, 33100
        • A.O.U. S. Maria Della Misericordia Di Udine
      • Verona, Italy, 37126
        • Ospedale Civile Maggiore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm B
Nab-paclitaxel 125 mg/mq weekly for 3 out of every 4 weeks
Drug: Nab-paclitaxel
comparison of different dosages of drug
Other Names:
  • Abraxane
Experimental: Arm A
Nab-paclitaxel 100 mg/mq weekly for 3 out of every 4 weeks
Drug: Nab-paclitaxel
comparison of different dosages of drug
Other Names:
  • Abraxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival (EFS)
Time Frame: Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient).
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)
Time Frame: Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient).
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)
Time Frame: Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient)
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)
Time Frame: Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient)
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)
Time Frame: Every 12 weeks until death or trial completion (12 months after randomization of the last patient)
Documentation of death
Every 12 weeks until death or trial completion (12 months after randomization of the last patient)
Incidence of adverse events
Time Frame: Every 12 weeks until event occurrence or trial completion (12 months after randomization of the last patient)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Sandro Pitigliani

Investigators

  • Principal Investigator: Laura Biganzoli, MD, Azienda USL Toscana Centro - Prato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2013

Primary Completion (Actual)

September 22, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFFECT
  • 2012-002707-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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