Study Comparing Full-dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid

August 16, 2023 updated by: Novartis
The aim of this prospective, randomized, open-label, multicentric clinical study is to assess the effícacy and tolerability of zoledronic acid 4 mg IV infused over 15 minutes every 4 weeks for a total of 6 infusions, in combination with standard or reduced dose radiotherapy in patients with breast cancer and metastatic bone disease associated with pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Novartis Investigative Site
      • Antalya, Turkey
        • Novartis Investigative Site
      • Bursa, Turkey
        • Novartis Investigative Site
      • Istanbul, Turkey
        • Novartis Investigative Site
      • Izmir, Turkey
        • Novartis Investigative Site
      • Kayseri, Turkey
        • Novartis Investigative Site
      • Trabzon, Turkey
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged ≥ 18 years.
  • Histologically confirmed diagnosis of breast cancer with at least one bone metastases.
  • Radiologically documented solitary or multiple osteolytic or osteoblastic lesions in axial skeleton or in the extremities in which radiotherapy is indicated.
  • Pain and/or analgesic score ≥ 3 (see section 3.5.2) at the bone site to be irradiated.
  • ECOG performance status ≤ 2.
  • Life expectancy more than 6 months.

Exclusion Criteria:

  • Patients in whom the target lesion(s) is not detectable by conventional techniques (i.e. X-rays MRI or CT scan).
  • Presence of pathological fracture in the target lesion(s).
  • Prior irradiation of the painful area(s) to be irradiated.
  • Known hypersensitivity to zoledronic acid or other biphosphonates.
  • Previous treatment with bisphosphonates for the current disease; any treatment with biphosphonates for other indications should anyway have been discontinued at least two years before randomization into the study.
  • Skeleton-related complications (e.g., pathological fractures, orthopedic intervention to treat or stabilize an osteolytic defect, spinal cord compression) during the last 3 weeks prior to the first infusion of trial medication.
  • Change in anticancer therapy within the 2 weeks prior to screening assessments and/or test treatment start.
  • Patients with severe renal function (serum creatinine > 400 umol/l or > 4.5 mg/dl or calculated creatinine clearance ≤ 30 ml/minute) or with prior renal transplantation. Creatinine clearance will be calculated using the following formula:

Creatinine clearance = (140-age[yr])(body weight [kg]) x 0.85 (72) (serum creatinine [mg/dL]) or Creatinine clearance = (140-age[yr])(body weight [kg]) x 0.85 (0.814) (serum creatinine [µmol/L])

  • Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L).
  • Patients with clinically symptomatic brain metastases
  • Bone metabolism disorder, e.g. Paget disease, primary hyperparathyroidism
  • Serious intercurrent illness other than breast cancer that can interfere with the evaluation of the effect of the therapy.
  • Pregnancy and lactation.
  • Women of childbearing potential not on an effective form of contraception.
  • Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient)
  • Patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZOL446 Standard radiotherapy dosage
Drug: Zoledronic acid
Other Names:
  • ZOL446
Experimental: ZOL446 Low radiotherapy dosage
Drug: Zoledronic acid
Other Names:
  • ZOL446

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients showing complete response in bone pain palliation without having any analgesic treatment
Time Frame: day 5, 12, 29; week 8, 12, 16, 20 & 24
day 5, 12, 29; week 8, 12, 16, 20 & 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446ETR01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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