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

Breast Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Karnofsky≥70 2. Provision of informed consent 3. Pathological confirmation of breast cancer 4. Hormone receptor-positive and accept aromatase inhibitors for adjuvant endocrine therapy 5. Not previously received treatment with bisphosphonate 6. Laboratory criteria: PLT≥100*109/L WBC≥4000/mm3 HGB≥10g/dl GOT,GPT,ALP≤2*ULN TBIL,DBIL,CCr≤1.5*ULN 7. Surgery , radiotherapy and chemotherapy has finished Exclusion Criteria: 1. Pregnant of lactation woman 2. History of organ transplantation 3. With mental disease 4. With severe infection or active gastrointestinal ulcers 5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes 6. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ) 7. With heart disease 8. Experimental drug allergy

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Breast Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Zoledronic Acid and Aromatase InhibitorsZoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Zoledronic Acid and Aromatase InhibitorsZoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy

Study Status

Unknown status

Start Date: January 2012

Completed Date: December 2013

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: therapeutic assessment

Secondary Outcome: Adverse reactions and disease-free survival

Study sponsors, principal investigator, and references

Principal Investigator: Jin Zhang, Professor

Lead Sponsor: Tianjin Medical University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01654367

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