CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 188 enrolled
Drug / intervention
MEDI-573 +1 moredrug
Likely dose
MEDI-573 45 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01446159
NCT01446159Phase 2Completed
CompareCT.gov

A Phase 1b/2 Randomized Study of MEDI-573 in Combination With an Aromatase Inhibitor (AI) Versus AI Alone in Women With Metastatic Breast Cancer (MBC)

MedImmune LLC·interventional·Posted Oct 5, 2011·Updated Jun 2, 2020

In Brief

A Phase 2 clinical trial evaluating MEDI-573 and Aromatase Inhibitor for Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer. Completed, enrolled 188 participants across 71 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHormone-sensitive, HER-2 Negative Metastatic Breast Cancer
CountriesBelgium, Canada, France, Germany, Hungary, Israel, Poland, Spain, The Bahamas, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2011
Enrollment StartJun 13, 2011
Primary CompletionJun 28, 2019
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 14.7 years ago

Interventions

MEDI-573drug

Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Aromatase Inhibitordrug

Aromatase inhibitor of the investigator's choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.