Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer

Novartis

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Placebo; Drug: Zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00320710

CZOL446E2352

Details and patient eligibility

About

Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.

Enrollment: 416 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Female patients ≥ 18 years of age. Confirmed breast cancer with bone metastasis. Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses;

Exclusion criteria

Abnormal kidney function determined by serum creatinine levels. Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.

Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants).

Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone).

Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 days prior to randomization.

Other protocol-defined exclusion criteria may have applied.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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416 participants in 3 patient groups

Zoledronic acid every (q) 4 weeks

Experimental group

Description:

Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.

Treatment:

Drug: Zoledronic acid

Zoledronic acid q 12 weeks

Experimental group

Description:

Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.

Treatment:

Drug: Zoledronic acid

Drug: Placebo

Placebo / zoledronic acid

Experimental group

Description:

Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were swithced to the zoledronic acid q 4 weeks according to a study amendment.

Treatment:

Drug: Zoledronic acid

Drug: Placebo