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

This study has been terminated.
Sponsor:
Collaborator:
Novartis
Information provided by:
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00130494
First received: August 12, 2005
Last updated: February 6, 2007
Last verified: February 2007
  Purpose

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.

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.

Condition Intervention Phase
Breast Cancer
Neoplasm Metastasis
Drug: Zoledronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open-Label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-Symptomatic Bone Lesions

Resource links provided by NLM:


Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:
  • Time to first bone metastases symptom

Secondary Outcome Measures:
  • Quality of life
  • Safety profile

Estimated Enrollment: 224
Study Start Date: August 2002
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130494

Locations
Spain
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Novartis
Investigators
Study Chair: Agustí Barnadas, MD.,PhD Spanish Breast Cancer Research Group (GEICAM)
Study Chair: Ana Lluch, MD.,PhD. Spanish Breast Cancer Research Group (GEICAM)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00130494     History of Changes
Other Study ID Numbers: GEICAM 2001-05
Study First Received: August 12, 2005
Last Updated: February 6, 2007
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Breast Cancer Research Group:
Non-symptomatic bone metastases.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014