Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients

NCT02511639 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-12-03

No results posted yet for this study

Summary

The purpose of this study is to compare maintenance Aromatase Inhibitors (AIs) + everolimus with Aromatase Inhibitors alone after 1st line chemotherapy in patients with HR+ metastatic breast cancer.

Conditions

  • Breast Cancer Metastatic

Interventions

DRUG

Everolimus

Everolimus is formulated as tablets of 10 mg strength for oral administration.

DRUG

Aromatase Inhibitors

Anastrozole is formulated as tablets of 1 mg strength for oral administration. Letrozole is formulated as tablets of 2.5 mg strength for oral administration. Exemestane is formulated as tablets of 25 mg strength for oral administration.

Sponsors & Collaborators

  • University of Padova

    collaborator OTHER
  • Istituto Oncologico Veneto IRCCS

    lead OTHER

Principal Investigators

  • Pierfranco Conte, MD, PhD · Medical Oncology 2, Istituto Oncologico Veneto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-30
Primary Completion
2020-02-28
Completion
2020-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

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 NCT02511639 on ClinicalTrials.gov