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

Novartis1 site in 1 country116 target enrollmentApril 2003

ConditionsBreast Cancer With Metastatic Bone Disease

InterventionsZoledronic acid

DrugsZoledronic acid

Overview

Phase: Phase 4
Intervention: Zoledronic acid
Conditions: Breast Cancer With Metastatic Bone Disease
Sponsor: Novartis
Enrollment: 116
Locations: 1
Primary Endpoint: Percentage of patients showing complete response in bone pain palliation without having any analgesic treatment
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

September 2005

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Novartis

Eligibility Criteria

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 ≤
•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).