Research of Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy to Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Zoledronic Acid and Aromatase Inhibitors
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Female
Criteria: 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
Location
Tianjin Cancer Hospital
Tianjin, Tianjin, China
Status: Recruiting
Contact: ZHANG SHENG, DOCTOR - 86-022-23340123
Start Date
January 2012
Completion Date
December 2013
Sponsors
Tianjin Medical University
Source
Tianjin Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page