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

NCT02783222 | Completed Phase 2

• 2 other identifiers: EFFECT2012-002707-18
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 14

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.

Conditions

Breast Cancer

Keywords

breast cancer; elderly patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Objective response rate (ORR)

  Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient).

• Clinical benefit rate (CBR)

  Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient)

• Progression free survival (PFS)

  Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient)

• Overall survival (OS)

  Every 12 weeks until death or trial completion (12 months after randomization of the last patient)

• Incidence of adverse events

  Every 12 weeks until event occurrence or trial completion (12 months after randomization of the last patient)

Study Arms (2)

Arm B

ACTIVE COMPARATOR

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

Drug: Nab-paclitaxel

Arm A

EXPERIMENTAL

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

Drug: Nab-paclitaxel

Interventions

Nab-paclitaxel DRUG

comparison of different dosages of drug

Also known as: Abraxane

Arm A; Arm B

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Sandro Pitigliani: lead

Study Sites (14)

A.O.U. Ospedali Riuniti

Ancona, 60100, Italy

Location

Centro Di Riferimento Oncologico

Aviano, 33081, Italy

Location

Azienda Ospedaliera Papa Giovanni Xxiii

Bergamo, 24127, Italy

Location

Spedali Civili Brescia

Brescia, 25125, Italy

Location

Ospedale Antonio Perrino

Brindisi, 72100, Italy

Location

Ospedale Ss. Trinita'

Frosinone, 09039, Italy

Location

Ospedale Vito Fazzi

Lecce, 73100, Italy

Location

Ausl 12 Viareggio

Lucca, 50053, Italy

Location

Istituto Europeo Oncologia

Milan, 20141, Italy

Location

A.O.U. Federico Ii Di Napoli

Napoli, 80131, Italy

Location

Istituto Oncologico Veneto

Padua, 35128, Italy

Location

Fondazione Maugeri

Pavia, 27100, Italy

Location

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

Udine, 33100, Italy

Location

Ospedale Civile Maggiore

Verona, 37126, Italy

Location

Related Publications (1)

• 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.

  PMID: 32758299 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Laura Biganzoli, MD

  Azienda USL Toscana Centro - Prato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 26, 2016
• Study Start: January 30, 2013
• Primary Completion: September 22, 2017
• Study Completion: December 1, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (14)