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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Sandro Pitigliani

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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