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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Tianjin Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zhang jin, Tianjin Medical University
ClinicalTrials.gov Identifier:
NCT01654367
First received: July 19, 2012
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Zoledronic Acid and Aromatase Inhibitors
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University:

Primary Outcome Measures:
  • therapeutic assessment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    therapeutic assessment


Secondary Outcome Measures:
  • Adverse reactions and disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Adverse reactions and disease-free survival


Other Outcome Measures:
  • Recurrence or death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Recurrence or death


Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Zoledronic Acid and Aromatase Inhibitors

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.

  Eligibility

Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Zhang jin, Tianjin Medical University
ClinicalTrials.gov Identifier: NCT01654367     History of Changes
Other Study ID Numbers: jzhang2
Study First Received: July 19, 2012
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014