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

NCT ID: NCT00130494

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-29
• Study Completion Date: 2007-10-22

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.

Conditions

Breast Cancer; Neoplasm Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Zoledronic acid 4 mg

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).

Group Type: EXPERIMENTAL

Zoledronic acid

Intervention Type: DRUG

Arm B: Observation

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Zoledronic acid

Intervention Type: DRUG

Other Intervention Names

Zometa

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Spanish Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Hospital Clínico Universitario de Valencia

Study Director

Role: STUDY_DIRECTOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

Spanish Breast Cancer Research Group (GEICAM)

San Sebastián de los Reyes, Madrid, Spain

Countries

Spain

Related Links

http://www.geicam.org

Click here for more information about this study: GEICAM 2001-05

Other Identifiers

GEICAM 2001-05

Identifier Type: -

Identifier Source: org_study_id