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Trial record 1 of 2 for:    2001-05
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Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00130494
Recruitment Status : Terminated (Low recruitment)
First Posted : August 15, 2005
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 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
Actual Study Start Date : August 29, 2002
Actual Primary Completion Date : November 20, 2006
Actual Study Completion Date : October 22, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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).
Drug: Zoledronic acid
Other Name: Zometa

No Intervention: 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).



Primary Outcome Measures :
  1. Time to first bone metastases [ Time Frame: Up to disease progression ]
    The main variable of evaluation is the time until the appearance of first bone metastases.


Secondary Outcome Measures :
  1. Quality of life per treatment arm [ Time Frame: Up to disease progression ]
    Quality of Life (QoL) will be measured with Short Form (SF)-36 questionnaire and Short questionnaire for the evaluation of pain since baseline visit and during all treatment period delivered to the patient before the start of each visit.

  2. The Number of Participants Who Experienced Adverse Events (AE) [ Time Frame: Through study treatment ]
    Safety will be assessed by standard clinical and laboratory tests. Adverse events grade will be defined by the NCI CTCAE.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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
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Study Director: Study Director Hospital Clínico Universitario de Valencia
Study Director: Study Director Hospital Santa Creu i Sant Pau
Additional Information:
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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00130494    
Other Study ID Numbers: GEICAM 2001-05
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Spanish Breast Cancer Research Group:
Non-symptomatic bone metastases.
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs