NCT00172029

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

2.4 years

First QC Date

September 13, 2005

Last Update Submit

August 16, 2023

Conditions

Breast Cancer With Metastatic Bone Disease

Keywords

Zoledronic acidRadiotherapyBone painBreast cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients showing complete response in bone pain palliation without having any analgesic treatment

    day 5, 12, 29; week 8, 12, 16, 20 & 24

Study Arms (2)

ZOL446 Standard radiotherapy dosage

EXPERIMENTAL
Drug: Zoledronic acid

ZOL446 Low radiotherapy dosage

EXPERIMENTAL
Drug: Zoledronic acid

Interventions

Zoledronic acidDRUG
Also known as: ZOL446
ZOL446 Low radiotherapy dosageZOL446 Standard radiotherapy dosage

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Novartis Investigative Site

Ankara, Turkey (Türkiye)

Location

Novartis Investigative Site

Antalya, Turkey (Türkiye)

Location

Novartis Investigative Site

Bursa, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, Turkey (Türkiye)

Location

Novartis Investigative Site

Kayseri, Turkey (Türkiye)

Location

Novartis Investigative Site

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

April 1, 2003

Primary Completion

September 1, 2005

Last Updated

August 18, 2023

Record last verified: 2023-08

Locations

TU(7)