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

Breast Cancer Clinical Trial

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Official title:

The Effectiveness and Safety of Treating Operable Breast Cancer by the Adjuvant Therapy of Zoledronic Acid and Aromatase Inhibitors and/or Ovarian Function Inhibition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01654367
• Other study ID #: jzhang2
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 19, 2012
• Last updated: July 26, 2012
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2012
• Source: Tianjin Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Cancer Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recurrence or death	Recurrence or death	5 years	Yes
Primary	therapeutic assessment	therapeutic assessment	6 months	Yes
Secondary	Adverse reactions and disease-free survival	Adverse reactions and disease-free survival	2 years	Yes