ClinicalTrials.Veeva

Menu

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

F

Fondazione Sandro Pitigliani

Status and phase

Completed
Phase 2

Conditions

Breast Cancer

Treatments

Drug: Nab-paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT02783222
EFFECT
2012-002707-18 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

Female

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Arm B
Active Comparator group
Description:
Nab-paclitaxel 125 mg/mq weekly for 3 out of every 4 weeks
Treatment:
Drug: Nab-paclitaxel
Arm A
Experimental group
Description:
Nab-paclitaxel 100 mg/mq weekly for 3 out of every 4 weeks
Treatment:
Drug: Nab-paclitaxel

Trial contacts and locations

14

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems