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Postoperative Use of Zoledronic Acid in Breast Cancer Patients After Neoadjuvant Chemotherapy

NCT00512993 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 654

Last updated 2015-03-05

No results posted yet for this study

Summary

The purpose of this study is to determine the event-free survival (EFS) after zoledronic acid for 5 years versus no postoperative treatment in patients with "chemo-insensitive" breast cancer (ypT1-4 and/or ypN1-3) after preoperative anthracycline/taxane containing chemotherapy

Conditions

Interventions

DRUG

Zoledronic acid

Infusion of zoledronic acid (4 mg) every 4 weeks for six doses, followed by every 3 months for 8 doses, followed by every 6 months for 5 doses

Sponsors & Collaborators

  • Austrian Breast & Colorectal Cancer Study Group

    collaborator NETWORK

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • GBG Forschungs GmbH

    lead OTHER

Principal Investigators

  • Gunter von Minckwitz, Prof. MD · GBG Forschungs GmbH, Hessen, Germany

  • Peter Dubsky, MD · Austrian Breast & Colorectal Cancer Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Austria
  • Germany

Study Locations

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Entities

Diseases
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 NCT00512993 on ClinicalTrials.gov