MedTrace Logo

Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer

NCT00242203 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-08-13

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Zometa

DRUG

Epirubicin

DRUG

Docetaxel

DRUG

Trastuzumab

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

RADIATION

External beam radiation

PROCEDURE

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Rebecca Aft, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2007-08-31
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00242203 on ClinicalTrials.gov