S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer

NCT02137837 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-01-28

Study results available
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Summary

This randomized Phase III trial studies how well the combination of fulvestrant and everolimus together or the combination of anastrozole, fulvestrant and everolimus together, improve progression-free survival (PFS) versus fulvestrant alone.

Conditions

Interventions

DRUG

Anastrozole

DRUG

Everolimus

DRUG

Placebo - Anastrozole

DRUG

Placebo - Everolimus

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY
  • Novartis

    collaborator INDUSTRY
  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Halle Moore, M.D. · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

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 NCT02137837 on ClinicalTrials.gov