Research of Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy to Breast Cancer

Study Overview
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Brief Summary
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Select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. Assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.

Detailed Description
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The investigators select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. Assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.

Official Title
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The Effectiveness and Safety of Treating Operable Breast Cancer by the Adjuvant Therapy of Zoledronic Acid and Aromatase Inhibitors and/or Ovarian Function Inhibition

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Zoledronic Acid and Aromatase Inhibitors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Karnofsky≥70 Provision of informed consent Pathological confirmation of breast cancer Hormone receptor-positive and accept aromatase inhibitors for adjuvant endocrine therapy Not previously received treatment with bisphosphonate Laboratory criteria: PLT≥100*109/L WBC≥4000/mm3 HGB≥10g/dl GOT,GPT,ALP≤2*ULN TBIL,DBIL,CCr≤1.5*ULN Surgery , radiotherapy and chemotherapy has finished Exclusion Criteria: Pregnant of lactation woman History of organ transplantation With mental disease With severe infection or active gastrointestinal ulcers With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ) With heart disease Experimental drug allergy
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoledronic Acid and Aromatase Inhibitors<br>Zoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy | Drug: Zoledronic Acid and Aromatase Inhibitors<br>* Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic assessment | therapeutic assessment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions and disease-free survival | Adverse reactions and disease-free survival | 2 years |