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

NCT01654367 | Unknown Phase 2 DMC

• 1 other identifier: jzhang2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• therapeutic assessment

  therapeutic assessment

  6 months

Secondary Outcomes (1)

• Adverse reactions and disease-free survival

  2 years

Other Outcomes (1)

• Recurrence or death

  5 years

Study Arms (1)

Zoledronic Acid and Aromatase Inhibitors

EXPERIMENTAL

Zoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy

Drug: Zoledronic Acid and Aromatase Inhibitors

Interventions

Zoledronic Acid and Aromatase Inhibitors DRUG

Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy

Zoledronic Acid and Aromatase Inhibitors

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Zoledronic Acid; Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Jin Zhang, Professor

  Tianjin Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tianjin Medical University

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 31, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

CN (1)