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

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ClinicalTrials.gov Identifier: NCT01654367
Recruitment Status : Unknown
Verified July 2012 by Zhang jin, Tianjin Medical University.
Recruitment status was:  Recruiting
First Posted : July 31, 2012
Last Update Posted : July 31, 2012
Sponsor:
Information provided by (Responsible Party):
Zhang jin, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Zoledronic Acid and Aromatase Inhibitors Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Zoledronic Acid and Aromatase Inhibitors
Zoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy
Drug: Zoledronic Acid and Aromatase Inhibitors
Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy



Primary Outcome Measures :
  1. therapeutic assessment [ Time Frame: 6 months ]
    therapeutic assessment


Secondary Outcome Measures :
  1. Adverse reactions and disease-free survival [ Time Frame: 2 years ]
    Adverse reactions and disease-free survival


Other Outcome Measures:
  1. Recurrence or death [ Time Frame: 5 years ]
    Recurrence or death



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654367


Locations
China, Tianjin
Tianjin Cancer Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: ZHANG SHENG, DOCTOR    86-022-23340123 ext 2901      
Contact: ZHANG SHENG, DORTOR    86-022-23340123 ext 2901      
Principal Investigator: ZHANG JIN, PROFESSOR         
Sponsors and Collaborators
Tianjin Medical University
Investigators
Study Chair: Jin Zhang, Professor TIANJIN CANCER HOSPITAL

Responsible Party: Zhang jin, Tianjin Medical University
ClinicalTrials.gov Identifier: NCT01654367     History of Changes
Other Study ID Numbers: jzhang2
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Zoledronic acid
Diphosphonates
Aromatase Inhibitors
Bone Density Conservation Agents
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists