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

Breast Cancer Clinical Trial

— EFFECT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783222
• Other study ID #: EFFECT
• Secondary ID: 2012-002707-18
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2016
• Last updated: January 9, 2018
• Start date: January 30, 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Fondazione Sandro Pitigliani
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2017
• Est. primary completion date: September 22, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Nab-paclitaxel
comparison of different dosages of drug

Locations

Country	Name	City	State
Italy	A.O.U. Ospedali Riuniti	Ancona
Italy	Centro Di Riferimento Oncologico	Aviano
Italy	Azienda Ospedaliera Papa Giovanni Xxiii	Bergamo
Italy	Spedali Civili Brescia	Brescia
Italy	Ospedale Antonio Perrino	Brindisi
Italy	Ospedale Ss. Trinita'	Frosinone
Italy	Ospedale Vito Fazzi	Lecce
Italy	Ausl 12 Viareggio	Lucca
Italy	Istituto Europeo Oncologia	Milano
Italy	A.O.U. Federico Ii Di Napoli	Napoli
Italy	Istituto Oncologico Veneto	Padova
Italy	Fondazione Maugeri	Pavia
Italy	A.O.U. S. Maria Della Misericordia Di Udine	Udine
Italy	Ospedale Civile Maggiore	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Sandro Pitigliani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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)
Secondary	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)
Secondary	Overall survival (OS)	Documentation of death	Every 12 weeks until death or trial completion (12 months after randomization of the last patient)
Secondary	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)