CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Zometa +5 moredrug
Likely dose
Not stated in 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/NCT00242203
NCT00242203Phase 2Completed
CompareCT.gov

Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer

Washington University School of Medicine·interventional·Posted Oct 19, 2005·Updated Aug 13, 2013

In Brief

A Phase 2 clinical trial evaluating Zometa, Epirubicin, and 4 other interventions for Breast Neoplasms. Completed, enrolled 120 participants across 1 site.

Detailed Summary

This study is designed to evaluate the impact of Zometa on clearance of bone marrow micrometastases; the protective effect on chemotherapy-induced loss of bone mineral density; and quality of life in women undergoing treatment for locally advanced breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesUnited States
CollaboratorsNovartis, Pfizer

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2005
Enrollment StartOct 1, 2002
Primary CompletionAug 1, 2007
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.7 years ago

Interventions

Zometadrug

Epirubicindrug

Docetaxeldrug

Trastuzumabdrug

ONLY for patients that are Her-2 overexpressing by 3+ by ICH for FSH

External beam radiationradiation

Modified radical mastectomy or breast conserving surgery with axillary lymph node dissectionprocedure