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

Phase 3TerminatedNCT00130494

Spanish Breast Cancer Research Group97 enrolled

Overview

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.

Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per treatment arm will be enrolled in the study. Once bone-related symptoms appear, study participation is over. During the study, the following will be assessed: * quality of life, * performance status, * pain rating, * analgesic administration and * adverse events The principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Neoplasm Metastasis

Interventions

Zoledronic acidDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Spanish Breast Cancer Research Group (GEICAM)

San Sebastián de los Reyes, Madrid, Spain

Outcomes

Primary Outcomes

Time to first bone metastases

The main variable of evaluation is the time until the appearance of first bone metastases.

Time frame: Up to disease progression

Secondary Outcomes

Quality of life per treatment arm

Quality of Life (QoL) will be measured with Short Form (SF)-36 questionnaire and Short questionnaire for the evaluation of pain since baseline visit and during all treatment period delivered to the patient before the start of each visit.

Time frame: Up to disease progression

The Number of Participants Who Experienced Adverse Events (AE)

Safety will be assessed by standard clinical and laboratory tests. Adverse events grade will be defined by the NCI CTCAE.

Time frame: Through study treatment

Data from ClinicalTrials.gov

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