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Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer

NCT02404051 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 745

Last updated 2016-06-15

No results posted yet for this study

Summary

This is a multi-center, randomized, open-label, parallel group study designed to evaluate efficacy and safety of fulvestrant followed, at progression, by examestane and everolimus versus examestane and everolimus followed, at progression, by fulvestrant in postmenopausal women with HR+ and HER2- LABC or MBC whose disease has progressed to NSAI in the adjuvant or metastatic setting.

Conditions

Interventions

DRUG

Everolimus

10 mg daily tablets

DRUG

Exemestane

25 mg daily tablets

DRUG

Fulvestrant

500 mg i.m. on Days 1, 15 and 29 and every 28 days thereafter

Sponsors & Collaborators

  • Clinical Research Technology S.r.l.

    collaborator INDUSTRY

  • Consorzio Oncotech

    lead OTHER

Principal Investigators

  • Sabino De Placido, MD · Dipartimento di Medicina Clinica e Chirurgia Oncologia Università degli Studi di Napoli "Federico II"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-01-31
Completion
2019-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02404051 on ClinicalTrials.gov