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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
Information provided by:
Spanish Breast Cancer Research Group

August 12, 2005
August 15, 2005
February 7, 2007
August 2002
Not Provided
Time to first bone metastases symptom
Time to first bone metastases symptom.
Complete list of historical versions of study NCT00130494 on ClinicalTrials.gov Archive Site
  • Quality of life
  • Safety profile
  • Quality of life.
  • Safety profile.
Not Provided
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Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-Symptomatic Bone Lesions
Multicenter, Open-Label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-Symptomatic Bone Lesions

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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer
  • Neoplasm Metastasis
Drug: Zoledronic acid
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2006
Not Provided

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.
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
GEICAM 2001-05
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Spanish Breast Cancer Research Group
Study Chair: Agustí Barnadas, MD.,PhD Spanish Breast Cancer Research Group (GEICAM)
Study Chair: Ana Lluch, MD.,PhD. Spanish Breast Cancer Research Group (GEICAM)
Spanish Breast Cancer Research Group
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP