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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00172029

Collaborator

(none)

116

Enrollment

Locations

Arms

16.6

Patients Per Site

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Sep 1, 2005

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Novartis Investigative Site	Ankara	Turkey
2	Novartis Investigative Site	Antalya	Turkey
3	Novartis Investigative Site	Bursa	Turkey
4	Novartis Investigative Site	Istanbul	Turkey
5	Novartis Investigative Site	Izmir	Turkey
6	Novartis Investigative Site	Kayseri	Turkey
7	Novartis Investigative Site	Trabzon	Turkey