Status:
TERMINATED
Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Novartis
Conditions:
Breast Cancer
Neoplasm Metastasis
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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 c...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 29 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2007
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00130494
Start Date
August 29 2002
End Date
October 22 2007
Last Update
April 16 2019
Active Locations (1)
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1
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700