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


Phase 2/Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

therapeutic assessment

Outcome Description:

therapeutic assessment

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Jin Zhang, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

TIANJIN CANCER HOSPITAL

Authority:

United States: Institutional Review Board

Study ID:

jzhang2

NCT ID:

NCT01654367

Start Date:

January 2012

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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