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?
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
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
Start Date: January 2012
Completed Date: December 2013
Phase: Phase 2/Phase 3
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