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COMPLETED Phase 2

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

NCT01797120 · View on ClinicalTrials.gov ↗

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

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

5 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PrECOG, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01797120 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Pennsylvania, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01797120?

The interventions under investigation include: Placebo (DRUG), Everolimus (DRUG), Fulvestrant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01797120?

This trial is sponsored by PrECOG, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial