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Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

NCT03176238 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2020-04-07

Study results available
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Summary

This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.

Conditions

  • Post Menopausal Breast Cancer

Interventions

DRUG

everolimus

one 10 mg tablet or two 5 mg tablets of everolimus were administered orally once daily on a continuous dosing schedule starting on Day 1

DRUG

exemestane

25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-29
Primary Completion
2019-01-29
Completion
2019-01-29

Countries

  • Australia
  • India
  • Indonesia
  • Jordan
  • Malaysia
  • Morocco
  • South Africa
  • South Korea
  • Taiwan
  • Thailand
  • Tunisia
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03176238 on ClinicalTrials.gov