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NCT01446159 · ClinicalTrials.gov registry record · Phase 2

Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer

A Phase 2 study of Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer, sponsored by MedImmune.

Completed
Registry status
Phase 2
Development phase
188
Enrollment target
20
Study locations

NCT01446159: Completed Phase 2 study of Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer, sponsored by MedImmune.

NCT01446159 is a Phase 2 study of Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer that has completed, run by MedImmune. The registered enrollment target is 188 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01446159, a Phase 2 study of Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer, has completed, sponsored by MedImmune.

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

Study Summary

Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.

Primary Outcome

An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened

Conditions Studied

Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer

Interventions

  • DRUG Aromatase Inhibitor
  • DRUG MEDI-573

Study Locations (20)

Maryland

  • Research Site - Baltimore
  • Research Site - Baltimore
  • Research Site - Bethesda
  • Research Site - Frederick
  • Research Site - Rockville

Florida

  • Research Site - Fort Myers
  • Research Site - Orlando
  • Research Site - Port Saint Lucie
  • Research Site - St. Petersburg

Georgia

  • Research Site - Athens
  • Research Site - Augusta
  • Research Site - Lawrenceville

California

  • Research Site - Bakersfield
  • Research Site - Pleasant Hill

Michigan

  • Research Site - Ann Arbor
  • Research Site - Lansing

Arizona

  • Research Site - Scottsdale

Connecticut

  • Research Site - Stamford

Maine

  • Research Site - Scarborough

Trial Details

FieldValue
Enrollment Target 188 participants
Start Date 2011-06-13
Est. Completion 2019-06-28
Phase Phase 2
MedImmune

210 total trials

What the finished NCT01446159 record still lists

NCT01446159 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher).

The record links to 1 condition, with Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Aromatase Inhibitor is the first listed.

NCT01446159 names 20 study sites across 9 states, led by Maryland, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT01446159 about?

NCT01446159 is a clinical study titled "Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer". Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.

What is the current status of trial NCT01446159?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 188 participants. The study started on 2011-06-13. Estimated completion is 2019-06-28.

What conditions does trial NCT01446159 study?

This clinical trial studies the following conditions: Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer.

What interventions are being tested in trial NCT01446159?

The interventions under investigation include: Aromatase Inhibitor (DRUG), MEDI-573 (DRUG).

Who is sponsoring clinical trial NCT01446159?

This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01446159 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT01446159's enrollment target sits among peer trials

188 356th of 2000 higher than 1,644 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01446159, the US trial registry maintained by the National Library of Medicine. NCT01446159 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.