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

Phase 3

Terminated

• Conditions: Breast Cancer; Neoplasm Metastasis
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT00130494
• Lead Sponsor: Spanish Breast Cancer Research Group

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2002-08-29
• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-15
• Primary Completion: 2006-11-20
• Study Completion: 2007-10-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 97

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Zoledronic acid 4 mg	Zoledronic acid	Zoledronate 4 mg every 3 or 4 weeks. This arm will receive study treatment from the time of entry into the trial, until the appearance of the symptoms of bone metastases (or a maximum period of 12 months, whichever occurs first).

Primary Outcome Measures

Name	Time	Method
Time to first bone metastases	Up to disease progression	The main variable of evaluation is the time until the appearance of first bone metastases.

Secondary Outcome Measures

Name	Time	Method
The Number of Participants Who Experienced Adverse Events (AE)	Through study treatment	Safety will be assessed by standard clinical and laboratory tests. Adverse events grade will be defined by the NCI CTCAE.
Quality of life per treatment arm	Up to disease progression	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.

Trial Locations

Locations (1)

Spanish Breast Cancer Research Group (GEICAM); 🇪🇸 San Sebastián de los Reyes, Madrid, Spain