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The main purpose of this study is to observe and assess the impact of adjuvant zoledronate on bone density in breast cancer patients.
The second purposes:
Breast cancer is the most commonly diagnosed malignant disease and the leading cause of cancer-related mortality among women.
Zoledronate is a bone-targeted bisphosphonate, which is used to treat osteoporosis and to reduce the risk of skeletal morbidity in patients with bone metastases. Zoledronate can also reduce the persistence of disseminated tumour cells in the bone marrow of women with early-stage breast cancer. Nowadays, consensus is emerging that certain subsets of patients with early-stage breast cancer may benefit from bisphosphonate therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronate | Drug | 4mg, IV (in the vein) every 6 months. Number of Cycles: up to the researcher or until unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Bone Mineral Density | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bone metastasis rate | From date of randomization until the date of bone metastasis, assessed up to 48 weeks. | |
| Disease-Free Survival | From date of randomization until the date of bone metastasis or date of death from any cause, whichever came first, assessed up to 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shenming Wang, MD, PhD | First Affiliated Hospital, Sun Yat-Sen University | Study Chair |
| Ying Lin, MD, PhD | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguan People's Hospital | Dongguan | Guangdong | 523059 | China | ||
| General Hospital of Guangzhou Military Command of PLA |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Guangzhou |
| Guangdong |
| 510010 |
| China |
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
| GuangDong Hospital Of Traditional Chinese Medicine | Guangzhou | Guangdong | 510120 | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
| Guangzhou First Municipal People's Hospital | Guangzhou | Guangdong | 510180 | China |
| Nanfang Hospital | Guangzhou | Guangdong | 510515 | China |
| The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | 510630 | China |
| Shenzhen Second Municipal People's Hospital | Shenzhen | Guangdong | China |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |