search
Back to results

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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Zoledronic Acid and Aromatase Inhibitors
Sponsored by
Tianjin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tianjin Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zoledronic Acid and Aromatase Inhibitors

Arm Description

Zoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy

Outcomes

Primary Outcome Measures

therapeutic assessment
therapeutic assessment

Secondary Outcome Measures

Adverse reactions and disease-free survival
Adverse reactions and disease-free survival

Full Information

First Posted
July 19, 2012
Last Updated
July 26, 2012
Sponsor
Tianjin Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT01654367
Brief Title
Research of Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy to Breast Cancer
Acronym
esozao
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic Acid and Aromatase Inhibitors
Arm Type
Experimental
Arm Description
Zoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid and Aromatase Inhibitors
Intervention Description
Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy
Primary Outcome Measure Information:
Title
therapeutic assessment
Description
therapeutic assessment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adverse reactions and disease-free survival
Description
Adverse reactions and disease-free survival
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Recurrence or death
Description
Recurrence or death
Time Frame
5 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Zhang, Professor
Organizational Affiliation
Tianjin Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZHANG SHENG, DOCTOR
Phone
86-022-23340123
Ext
2901
First Name & Middle Initial & Last Name & Degree
ZHANG SHENG, DORTOR
Phone
86-022-23340123
Ext
2901
First Name & Middle Initial & Last Name & Degree
ZHANG JIN, PROFESSOR

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs