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

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ClinicalTrials.gov Identifier: NCT00130494
Recruitment Status : Terminated
First Posted : August 15, 2005
Last Update Posted : February 7, 2007
Sponsor:
Collaborator:
Novartis
Information provided by:
Spanish Breast Cancer Research Group

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.

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 or disease Intervention/treatment Phase
Breast Cancer Neoplasm Metastasis Drug: Zoledronic acid Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2002
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. Time to first bone metastases symptom

Secondary Outcome Measures :
  1. Quality of life
  2. Safety profile


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

Additional Information:
ClinicalTrials.gov Identifier: NCT00130494     History of Changes
Other Study ID Numbers: GEICAM 2001-05
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: February 7, 2007
Last Verified: February 2007

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

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