Status:
COMPLETED
Study Comparing Full-dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid
Lead Sponsor:
Novartis
Conditions:
Breast Cancer With Metastatic Bone Disease
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00172029
Start Date
April 1 2003
Last Update
August 18 2023
Active Locations (7)
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1
Novartis Investigative Site
Ankara, Turkey (Türkiye)
2
Novartis Investigative Site
Antalya, Turkey (Türkiye)
3
Novartis Investigative Site
Bursa, Turkey (Türkiye)
4
Novartis Investigative Site
Istanbul, Turkey (Türkiye)