Breast Cancer With Metastatic Bone Disease Clinical Trial
Official title:
Study Comparing Full-dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid
| NCT number | NCT00172029 |
| Other study ID # | CZOL446ETR01 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | April 2003 |
| Verified date | August 2023 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 116 |
| Est. completion date | |
| Est. primary completion date | September 2005 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |