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

NCT00130494 | Terminated Phase 3

• 1 other identifier: GEICAM 2001-05
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Neoplasm Metastasis

Keywords

Non-symptomatic bone metastases.

Outcome Measures

Primary Outcomes (1)

• Time to first bone metastases

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

  Up to disease progression

Secondary Outcomes (2)

• Quality of life per treatment arm

  Up to disease progression

• The Number of Participants Who Experienced Adverse Events (AE)

  Through study treatment

Study Arms (2)

Arm A: Zoledronic acid 4 mg

EXPERIMENTAL

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).

Drug: Zoledronic acid

Arm B: Observation

NO INTERVENTION

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).

Interventions

Zoledronic acid DRUG

Also known as: Zometa

Arm A: Zoledronic acid 4 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Novartis: collaborator

Study Sites (1)

Spanish Breast Cancer Research Group (GEICAM)

San Sebastián de los Reyes, Madrid, 28700, Spain

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Study Director

  Hospital Clínico Universitario de Valencia

  STUDY DIRECTOR

• Study Director

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: August 29, 2002
• Primary Completion: November 20, 2006
• Study Completion: October 22, 2007
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

ES (1)