Clinical trial NCT00130494: Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
Official title: Multicenter, Open-label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-symptomatic Bone Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Neoplasm Metastasis
Keywords: Non-symptomatic bone metastases.
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2005-08-15
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Time to first bone metastases
timeFrame: Up to disease progression
Secondary outcomes:
measure: Quality of life per treatment arm
timeFrame: Up to disease progression
measure: The Number of Participants Who Experienced Adverse Events (AE)
timeFrame: Through study treatment
Other outcomes:
Locations:
city: San Sebastián de los Reyes
country: Spain
facility: Spanish Breast Cancer Research Group (GEICAM)
state: Madrid
Study officials:
affiliation: Hospital Clínico Universitario de Valencia
name: Study Director
role: STUDY_DIRECTOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Study Director
role: STUDY_DIRECTOR
References: