Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow

Study Overview
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Brief Summary
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Metastatic bone disease is an important prognostic factor for survival which will in median be close to two years after first diagnosis of osseous metastases. This open-label study will investigate the safety and efficacy of zoledronic acid in patients with breast cancer and minimal residual disease in the bone marrow.

Official Title
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Efficacy and Tolerability of Intravenous Zometa® (Zoledronic Acid) 4 mg in Primary Breast Cancer Patients With Disseminated Tumor Cells in Bone Marrow. A Prospective, Randomized, Parallel Group, Open-label, Clinical Pilot Study.

Conditions
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Primary Breast Cancer

Intervention / Treatment
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* Drug: Zoledronic acid + Calcium/Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, with primary breast cancer who had undergone complete primary tumor resection and axillary lymph node dissection Evidence of minimal residual disease (disseminated tumor cells in bone marrow) Patients had to receive one of the following adjuvant therapy categories: chemotherapy ± hormonal therapy or hormonal therapy alone Exclusion Criteria: Inflammatory, metastatic or recurrent breast cancer or a history of breast cancer prior to the currently diagnosed case Neo-adjuvant chemotherapy, neo-adjuvant hormonal therapy, or neo-adjuvant radiotherapy Prior stem cell rescue/bone marrow transplant History of other cancers aside from non-melanomatous skin cancer or carcinoma in situ of the uterine cervix Additional protocol-defined inclusion / exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br> | Drug: Zoledronic acid + Calcium/Vitamin D<br> <br> |
| Active Comparator: Control Group<br> | Drug: Zoledronic acid + Calcium/Vitamin D<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of detected tumor cells in bone marrow |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline). |  | 24 months | 
| Bone metastases-free survival |  | 24 months | 
| Disease-free survival |  | 24 months | 
| Bone mineral density |  | at 12 and 24 months | 
| Number and localization of bone metastases |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary breast cancer, Bone metastases, Minimal residual disease, Bisphosphonates