Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions

• Status: Terminated
• Trial end date: 2007-10-22
• Target enrollment: 0
• Participant gender: Female

Summary

This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Breast Cancer Research Group
• Collaborator: Novartis
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Written informed consent.

• Age >= 18 years old.

• Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.

• Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease.

• A maximum of two chemotherapy lines for metastatic disease.

• A maximum of two hormone therapy lines for metastatic disease.

• Normal, minimally altered renal function (serum creatinine < 1.5 x Upper Normal Limit (UNL)).

• Normal serum calcium levels.

• Performance status 0,1 (World Health Organization (WHO)).

• Negative pregnancy test before study recruitment.

Exclusion Criteria:

• Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization.

• Metastasis in CNS.

• History of hypersensitivity to bisphosphonates.

• Pregnant or lactating women.

• Third chemotherapy line for metastatic disease.

• Third hormone therapy line for metastatic disease.

• Males.