MedTrace Logo

Phase II Study of Everolimus Beyond Progression

NCT02269670 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-04-05

Study results available
· View outcomes & findings →

Summary

This phase II trial studies how well everolimus and hormone therapy work in treating patients with hormone receptor positive breast cancer that has continued to spread (progressed) or returned after a period of improvement (recurred) on everolimus and exemestane hormone therapy. Everolimus is a chemotherapy drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen and progesterone are hormones that can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by lowering the amount of estrogen and progesterone the body makes. Giving everolimus with a different type of hormone therapy may be an effective treatment for breast cancer in patients who progressed on everolimus with exemestane.

Conditions

  • Estrogen Receptor-positive Breast Cancer
  • HER2-negative Breast Cancer
  • Progesterone Receptor-positive Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer

Interventions

DRUG

everolimus

Given PO

DRUG

anastrozole

Given PO

DRUG

letrozole

Given PO

DRUG

tamoxifen citrate

Given PO

DRUG

fulvestrant

Given IM or PO

DRUG

megestrol acetate

Given PO

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Suchita Pakkala, MD · Emory University/Winship Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-25
Primary Completion
2021-01-25
Completion
2021-01-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT02269670 on ClinicalTrials.gov