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

NCT ID: NCT02783222

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-30
• Study Completion Date: 2017-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm B

Nab-paclitaxel 125 mg/mq weekly for 3 out of every 4 weeks

Group Type: ACTIVE_COMPARATOR

Nab-paclitaxel

Intervention Type: DRUG

comparison of different dosages of drug

Arm A

Nab-paclitaxel 100 mg/mq weekly for 3 out of every 4 weeks

Group Type: EXPERIMENTAL

Nab-paclitaxel

Intervention Type: DRUG

comparison of different dosages of drug

Interventions

Nab-paclitaxel

comparison of different dosages of drug

Intervention Type: DRUG

Other Intervention Names

Abraxane

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Sandro Pitigliani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Biganzoli, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda USL Toscana Centro - Prato

Locations

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

Milan, , Italy

A.O.U. Federico Ii Di Napoli

Napoli, , Italy

Istituto Oncologico Veneto

Padua, , Italy

Fondazione Maugeri

Pavia, , Italy

A.O.U. S. Maria Della Misericordia Di Udine

Udine, , Italy

Ospedale Civile Maggiore

Verona, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32758299 (View on PubMed)

Other Identifiers

2012-002707-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFFECT

Identifier Type: -

Identifier Source: org_study_id