The Effectiveness and Safety of Treating Operable Breast Cancer by the Adjuvant Therapy of Zoledronic Acid and Aromatase Inhibitors and/or Ovarian Function Inhibition
Overview
- Phase
- Phase 2
- Intervention
- Zoledronic Acid and Aromatase Inhibitors
- Conditions
- Breast Cancer
- Sponsor
- Tianjin Medical University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- therapeutic assessment
- Last Updated
- 13 years ago
Overview
Brief Summary
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
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.
Investigators
Zhang jin
Tianjin Medical University
Tianjin Medical University
Eligibility Criteria
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
Arms & Interventions
Zoledronic Acid and Aromatase Inhibitors
Zoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy
Intervention: Zoledronic Acid and Aromatase Inhibitors
Outcomes
Primary Outcomes
therapeutic assessment
Time Frame: 6 months
therapeutic assessment
Secondary Outcomes
- Adverse reactions and disease-free survival(2 years)