Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01797120 · ClinicalTrials.gov registry record · Phase 2

Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI

A Phase 2 study of Metastatic Breast Cancer, sponsored by PrECOG.

Completed
Registry status
Phase 2
Development phase
131
Enrollment target
20
Study locations

NCT01797120 is a Phase 2 study of Metastatic Breast Cancer that has completed, run by PrECOG. The registered enrollment target is 131 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 11 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01797120, a Phase 2 study of Metastatic Breast Cancer, has completed, sponsored by PrECOG.

COMPLETED
Registry status
Phase 2
Development phase
131 participants
Enrollment target
20
Study locations

Study Summary

Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients). Fulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy. Everolimus is an orally administered drug that blocks a signaling pathway called "mTOR". "mTOR" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth. The combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.

Conditions Studied

Metastatic Breast Cancer

Interventions

  • DRUG Placebo
  • DRUG Everolimus
  • DRUG Fulvestrant

Study Locations (20)

Pennsylvania

  • Hematology & Oncology Associates of Northeastern PA, PC - Dunmore
  • Penn State University - Hershey
  • Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center - Philadelphia
  • University of Pittsburgh- Magee Women's Hospital - Pittsburgh
  • Reading Hospital- McGlinn Family Regional Cancer Center - West Reading
  • Main Line Heath System - Wynnewood

California

  • Marin Cancer Care - Greenbrae
  • Stanford University - Stanford

New York

  • Beth Israel - New York
  • Montefiore Medical Center - The Bronx

Ohio

  • Ohio State University Medical Center - Columbus
  • Toledo COP - Toledo

Illinois

  • SwedishAmerican Regional Cancer Center - Rockford

Iowa

  • McFarland Clinic, PC - Ames

Maryland

  • Johns Hopkins University - Baltimore

Michigan

  • St. Joseph Mercy Hospital (MI Cancer Consortium) - Ann Arbor

Trial Details

FieldValue
Enrollment Target 131 participants
Start Date 2013-05-31
Est. Completion 2017-09-12
Phase Phase 2

Sponsor

PrECOG

17 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01797120

The ClinicalTrials.gov registry entry for NCT01797120 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (36% lower). The listed sponsor is PrECOG, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01797120 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Pennsylvania, California, New York.

Frequently Asked Questions

What is clinical trial NCT01797120 about?

NCT01797120 is a clinical study titled "Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI". Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients). Fulvestrant has demonstrated activ...

What is the current status of trial NCT01797120?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2013-05-31. Estimated completion is 2017-09-12.

What conditions does trial NCT01797120 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer.

What interventions are being tested in trial NCT01797120?

The interventions under investigation include: Placebo (DRUG), Everolimus (DRUG), Fulvestrant (DRUG).

Who is sponsoring clinical trial NCT01797120?

This trial is sponsored by PrECOG, which has 17 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01797120 being conducted?

This trial has 20 study locations across California, Illinois, Iowa, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Metastatic Breast Cancer

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.