Clinical trial NCT02783222: EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly With advanCed breasT Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
elderly patients
Lead sponsor: Fondazione Sandro Pitigliani
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 160
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient).
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient).
measure: Clinical benefit rate (CBR)
timeFrame: Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient)
measure: Progression free survival (PFS)
timeFrame: Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient)
measure: Overall survival (OS)
timeFrame: Every 12 weeks until death or trial completion (12 months after randomization of the last patient)
measure: Incidence of adverse events
timeFrame: Every 12 weeks until event occurrence or trial completion (12 months after randomization of the last patient)
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti
city: Aviano
country: Italy
facility: Centro Di Riferimento Oncologico
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni Xxiii
city: Brescia
country: Italy
facility: Spedali Civili Brescia
city: Brindisi
country: Italy
facility: Ospedale Antonio Perrino
city: Frosinone
country: Italy
facility: Ospedale Ss. Trinita'
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Lucca
country: Italy
facility: Ausl 12 Viareggio
city: Milano
country: Italy
facility: Istituto Europeo Oncologia
city: Napoli
country: Italy
facility: A.O.U. Federico Ii Di Napoli
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Pavia
country: Italy
facility: Fondazione Maugeri
city: Udine
country: Italy
facility: A.O.U. S. Maria Della Misericordia Di Udine
city: Verona
country: Italy
facility: Ospedale Civile Maggiore
Study officials:
affiliation: Azienda USL Toscana Centro - Prato
name: Laura Biganzoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biganzoli L, Cinieri S, Berardi R, Pedersini R, McCartney A, Minisini AM, Caremoli ER, Spazzapan S, Magnolfi E, Brunello A, Risi E, Palumbo R, Leo S, Colleoni M, Donati S, De Placido S, Orlando L, Pistelli M, Parolin V, Mislang A, Becheri D, Puglisi F, Sanna G, Zafarana E, Boni L, Mottino G. EFFECT: a randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer. Breast Cancer Res. 2020 Aug 5;22(1):83. doi: 10.1186/s13058-020-01319-1.