S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone

Phase 3

Withdrawn

• Conditions: Breast Cancer; Hypercalcemia of Malignancy; Metastatic Cancer; Pain
• Interventions: Drug: zoledronate; Drug: ibandronate; Procedure: quality-of-life assessment

• Registration Number: NCT00301886
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

RATIONALE: Zoledronate and ibandronate may prevent or help relieve bone pain and other symptoms caused by bone metastases. It is not yet known whether zoledronate is more effective than ibandronate in preventing bone problems caused by bone metastases due to breast cancer.

PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to ibandronate in preventing bone problems in women with stage IV breast cancer that has spread to the bone.

Detailed Description

OBJECTIVES:

Primary

* Compare the efficacy of zoledronate vs ibandronate, in terms of preventing the occurrence of skeletal-related events (SRE) (e.g., fracture, spinal cord compression, radiotherapy or surgery for bone symptoms or events, or hypercalcemia ≥ grade 3), in women with stage IV breast cancer and bone metastases.

Secondary

* Compare the change in patient-reported measures of pain and use of analgesics in patients treated with these drugs.

* Compare the time to first clinically apparent SRE in patients treated with these drugs.

* Compare the toxicity of these drugs.

* Compare the changes in performance status and overall survival of patients treated with these drugs.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to hormone receptor status (estrogen receptor \[ER\] and progesterone receptor \[PR\] negative vs ER and/or PR positive) and current evidence of fracture (vertebral or nonvertebral) or spinal compression (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral ibandronate once daily on days 1-28.

* Arm II: Patients receive zoledronate IV over 15 minutes on day 1. In both arms, treatment repeats every 28 days for up to 18 courses in the absence of unacceptable toxicity.

Quality of life and pain are assessed at baseline, every 3 courses during study treatment, and at the end of study treatment.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study.

Study Timeline

• Study First Submitted: 2006-03-09
• Study First Submitted QC: 2006-03-09
• Study First Posted: 2006-03-13
• Study Start: 2006-05
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
zoledronate	quality-of-life assessment	zoledronate
ibandronate	quality-of-life assessment	ibandronate
zoledronate	zoledronate	zoledronate
ibandronate	ibandronate	ibandronate

Primary Outcome Measures

Name	Time	Method
Skeletal-related events (SRE)

Secondary Outcome Measures

Name	Time	Method
Survival and time to first clinically apparent SRE
Change in patient's rating of worst pain as measured by the Brief Pain Inventory
Changes in performance status
Tolerability and toxicity as measured by NCI CTCAE v3.0