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Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients

NCT01129336 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-05-20

Study results available
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Summary

This study will evaluate zoledronic acid's anti-cancer effects and Circulating Tumor Cell (CTCs) measurements in patients with HER2-negative metastatic breast cancer without bone metastasis.

Conditions

  • First or Second Line HER2-negative Breast Cancer
  • Metastatic Disease Without Bone Metastasis

Interventions

DRUG

Zoledronic acid

Patients with no bone metastasis (n=150) will receive Standard therapy plus Zoledronic acid administration 4 mg IV monthly during Months 1-18.

DRUG

Standard Therapy

Standard Therapy, including chemotherapy and hormonal therapy, was determined at the discretion of the investigator.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

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 NCT01129336 on ClinicalTrials.gov