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

Spanish Breast Cancer Research Group (GEICAM)

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer; Neoplasm Metastasis

Treatments: Drug: Zoledronic acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00130494

GEICAM 2001-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Arm A: Zoledronic acid 4 mg

Experimental group

Description:

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).

Treatment:

Drug: Zoledronic acid

Arm B: Observation

No Intervention group

Description:

Patients will not receive any treatment with bisphosphonates until the time of onset of symptoms (or a maximum period of 12 months, whichever occurs sooner).