Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer

Study Overview
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Brief Summary
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Triple-negative breast cancer is a special type of breast cancer with poor prgnosis and limited choices. Chemotherapy is the only choice of adjuvant systemic treatment options. Previous study suggested that zoledronic acid might have anti-tumor effect by eliminating the number of DTCs(Disseminated Tumor Cell )and had been proved to be effective as adjvant therapy in postmenopausal women whose breast cancer was Homonal receptor positive and who were receiving aromatase inhibitors. So it might be able to improve the survival of triple negative breast cancer patients.

Detailed Description
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Triple negative breast cancer patients with high risk factor will be randomized to receive either zoledronic acid or observation after the completion of standard chemotherapy/radiotherapy. Recurrence status will be followed and Disease free survival will be compared. Overall survival is the secondary endpoint.

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: Zoledronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •Adult women (≥ 18 years of age) with early stage breast cancer(stage II-III). Histological confirmation of estrogen and/or progesterone-receptor negative (ER-), human epidermal growth factor receptor 2 negative (HER2 -) breast cancer. ER/PR negative: nuclear reaction< 1%, HER2 negative: HER2; IHC 0,1+ or FISH/CISH (-) in case of IHC 2+ axillary lymph node positive with other high risk factors: LVI, T>5CM, Grade III Patients finish standard chemotherapy and/or radiotherapy ECOG performance status of 0,1 Adequate bone marrow, hepatic, and renal function Adequate bone marrow and coagulation function as shown by: Absolute neutrophil count (ANC) ≥ 1.5 109/L;Platelets>100 x109/L;Hemoglobin (Hgb) > 9.0g/dLINR < 2 Adequate liver function as shown by: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5x ULN Total serum bilirubin < 1.5 x ULN Adequate renal function as shown by: Serum creatinine< 1.5 x ULN Fasting serum cholesterol <300 mg/dL or 7.75 mmol/L and fasting triglycerides <2.5 x ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved. Written informed consent Exclusion Criteria: •Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer. Any severe and/or uncontrolled medical conditions, eg. currently active infection Pregnant or lactating Patients unwilling to or unable to comply with the protocol

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: A<br>zoledronic acid received | Drug: Zoledronic acid<br> <br> |
| No Intervention: B<br>observation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | the time from randomization to the time of disease progression or relapse or death | 3 years after last patient was enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | the time from randomization to the time of death | 5 years after last patient was enrolled | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | up to 28 days after last medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zoledronic acid, triple-negative breast cancer, adjuvant treatment