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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Zoledronic Acid and Aromatase Inhibitors

• Registration Number: NCT01654367
• Lead Sponsor: Tianjin Medical University

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.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-07
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-26
• Last Update Submitted: 2012-07-26
• Study First Posted: 2012-07-31
• Last Update Posted: 2012-07-31
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zoledronic Acid and Aromatase Inhibitors	Zoledronic Acid and Aromatase Inhibitors	Zoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy

Primary Outcome Measures

Name	Time	Method
therapeutic assessment	6 months	therapeutic assessment

Secondary Outcome Measures

Name	Time	Method
Adverse reactions and disease-free survival	2 years	Adverse reactions and disease-free survival

Trial Locations

Locations (1)

Tianjin Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China