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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 13, 2005
Last updated: March 26, 2010
Last verified: March 2010
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.

Condition Intervention Phase
Breast Cancer With Metastatic Bone Disease Drug: Zoledronic acid Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Comparing Full-dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Enrollment: 116
Study Start Date: April 2003
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZOL446 Standard radiotherapy dosage Drug: Zoledronic acid
Other Name: ZOL446
Experimental: ZOL446 Low radiotherapy dosage Drug: Zoledronic acid
Other Name: ZOL446


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00172029

Novartis Investigative Site
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
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00172029     History of Changes
Other Study ID Numbers: CZOL446ETR01
Study First Received: September 13, 2005
Last Updated: March 26, 2010

Keywords provided by Novartis:
Zoledronic acid
Bone pain
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Bone Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Musculoskeletal Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on June 22, 2017