CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 252 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
AMG 162 (denosumab) 60 mg subcutaneously every 6 months for 24 monthsAI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed adenocarcinoma of the breast
  • ✓Early stage, estrogen receptor positive disease
  • ✓Completed all cancer treatment (surgery, chemotherapy, radiation, hormone therapy) with ≥4 weeks washout
  • ✓Currently on or will initiate aromatase inhibitor therapy for the full 24-month study duration
Key exclusion· 1
  • ✕Acute toxic effects from prior treatment not resolved to ≤Grade 1 per CTCAE

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

Search/NCT00089661
NCT00089661Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

Amgen·interventional·Posted Aug 11, 2004·Updated Oct 17, 2018

In Brief

A Phase 3 clinical trial evaluating Placebo and AMG 162 / Denosumab for Breast Cancer and 2 related conditions. Completed, enrolled 252 participants.

Detailed Summary

The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Low Bone Mineral Density, Osteopenia
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2004
Enrollment StartOct 1, 2004
Primary CompletionMay 11, 2007
Study CompletionMay 27, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 21.9 years ago

Interventions

Placebodrug

60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months

AMG 162 / Denosumabdrug

60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months