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

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ClinicalTrials.gov Identifier: NCT02783222
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Fondazione Sandro Pitigliani

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Nab-paclitaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 30, 2013
Actual Primary Completion Date : September 22, 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

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 Name: 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 Name: Abraxane




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Overall survival (OS) [ Time Frame: Every 12 weeks until death or trial completion (12 months after randomization of the last patient) ]
    Documentation of death

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783222


Locations
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Italy
A.O.U. Ospedali Riuniti
Ancona, Italy, 60100
Centro Di Riferimento Oncologico
Aviano, Italy, 33081
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo, Italy, 24127
Spedali Civili Brescia
Brescia, Italy, 25125
Ospedale Antonio Perrino
Brindisi, Italy, 72100
Ospedale Ss. Trinita'
Frosinone, Italy, 09039
Ospedale Vito Fazzi
Lecce, Italy, 73100
Ausl 12 Viareggio
Lucca, Italy, 50053
Istituto Europeo Oncologia
Milano, Italy, 20141
A.O.U. Federico Ii Di Napoli
Napoli, Italy, 80131
Istituto Oncologico Veneto
Padova, Italy, 35128
Fondazione Maugeri
Pavia, Italy, 27100
A.O.U. S. Maria Della Misericordia Di Udine
Udine, Italy, 33100
Ospedale Civile Maggiore
Verona, Italy, 37126
Sponsors and Collaborators
Fondazione Sandro Pitigliani
Investigators
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Principal Investigator: Laura Biganzoli, MD Azienda USL Toscana Centro - Prato
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione Sandro Pitigliani
ClinicalTrials.gov Identifier: NCT02783222    
Other Study ID Numbers: EFFECT
2012-002707-18 ( EudraCT Number )
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fondazione Sandro Pitigliani:
breast cancer
elderly patients
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action