Trial intelligence / Profile preview

4EVER: Everolimus + Exemestane in Advanced Breast Cancer

NCT01626222Phase 3

Key facts

Status: Completed
Start: Jun 2012
Primary completion: Nov 2013
Countries: 1
Sponsor: Novartis
Modality: Small Molecules

Drugs: everolimus
Conditions: breast cancer

Overview

Phase 3, open-label, single-arm trial of everolimus in breast cancer, sponsored by Novartis. Primary endpoint: Overall Response Rate at 24 weeks. Started Jun 2012; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Everolimus & Exemestane
Everolimus (10 mg/day) + Exemestane (25 mg/day)

Who it enrols

Postmenopausal women with ER+ and/or PgR+, HER2- locally advanced or metastatic breast cancer progressing after NSAI therapy (Letrozole or Anastrozole).

Endpoints

Primary

Overall Response Rate24 weeks

Secondary

Progression Free Survival48 weeks
Overall Response Rate48 weeks
Overall Survival48 weeks
Safety and Tolerability48 weeks
Health Resource Utilization48 weeks
Health-related Quality of Life48 weeks

Beyond the preview

Go deeper on NCT01626222.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01626222.