Clinical trial NCT00375427: Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions
Official title: A Prospective, Randomized, Multi-center Comparative 2-arm Trial of Efficacy and Safety of Zoledronic Acid (Every 3-months vs. Every 4 Weeks) Beyond Approximately 1 Year of Treatment With Zoledronic Acid in Patients With Bone Lesions From Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer With Bone Metastasis
Keywords: Breast cancer
Zoledronic acid
Skeletal related events (SRE)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-13
Enrollment: 430
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the clinical benefit of two different dosing schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who have already been treated with zoledronic acid for about one year.


Eligibility criteria: Inclusion criteria:

* Female patients ≥ 18 years of age.
* Written informed consent given.
* Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed.
* Previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 .
* Life expectancy ≥ 1 year.

Exclusion criteria:

* More than 3 months since last infusion of Zoledronic Acid (Zometa®).
* Treatments with other bisphosphonate than Zoledronic Acid (Zometa®) at any time prior to study entry.
* Serum creatinine \> 3 mg/dL (265 μmol/L) or calculated (Cockcroft-Gault formula) creatinine clearance (CLCr) \< 30 mL/min CrCl = ({\[140-age (years)\] x weight(kg)}/ \[72 x serum creatinine (mg/dL)\])x 0.85
* Corrected (adjusted for serum albumin) serum calcium \< 8 mg/dl (2 mmol/L) or \> 12 mg/dL ( 3.0 mmol/L).
* Current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
* Pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. Women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide).
* History of non-compliance to medical regimens or potential unreliable behavior.
* Known sensitivity to study drug(s) or class of study drug(s).
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Use of any other investigational agent in the last 30 days.

Primary outcomes:
measure: Annual Overall Skeletal Morbidity Rate (SMR)
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants Experiencing Skeletal Related Event(s) (SREs)
timeFrame: 12 month
measure: Annual Incidence of Any Skeletal Related Events (SREs)
timeFrame: 12 months
measure: Median Time to First Skeletal Related Event(s) (SRE)
timeFrame: 12 month
measure: Percentage of Participants Skeletal Related Event (SRE) Free
timeFrame: 12 months
measure: Composite Bone Pain Score According to the Brief Pain Inventory (BPI) Questionnaire
timeFrame: At Baseline, Month 3, Month 6, Month 9 and Month 12
measure: Evaluation of Pain According to Verbal Rating Scale (VRS) Based on Median Score Value
timeFrame: At Baseline, Month 3, Month 6, Month 9 and Month 12
measure: Use Of Analgesic Medications According to the Analgesic Score Scale
timeFrame: At Baseline, Month 3, Month 6, Month 9 and Month 12
measure: Assessment of the Eastern Cooperative Oncology Group (ECOG) Performance Score
timeFrame: At Baseline, Month 3, Month 6, Month 9 and Month 12
Other outcomes:
Locations:
city: Forlì
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: