Bone Loss Treatment From Adjuvant Zoledronate Efficacy (BLAZE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Ying Lin, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01623908
First received: June 16, 2012
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

The main purpose of this study is to observe and assess the impact of adjuvant zoledronate on bone density in breast cancer patients.

The second purposes:

  • The efficacy of adjuvant zoledronate
  • The safety of adjuvant zoledronate
  • The bone loss of breast cancer patients in Guangdong
  • The correlation between bone loss of breast cancer patients and treatment of disease in Guangdong

Condition Intervention
Breast Neoplasms
Bone Loss
Drug: Zoledronate

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open,Multicentre,Prospective Study of Adjuvant Zoledronate Treatment in Osteoporosis Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • Change from Baseline in Bone Mineral Density [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bone metastasis rate [ Time Frame: From date of randomization until the date of bone metastasis, assessed up to 48 weeks. ] [ Designated as safety issue: Yes ]
  • Disease-Free Survival [ Time Frame: From date of randomization until the date of bone metastasis or date of death from any cause, whichever came first, assessed up to 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoledronate Drug: Zoledronate
4mg, IV (in the vein) every 6 months. Number of Cycles: up to the researcher or until unacceptable toxicity develops.
Other Name: Zometa

Detailed Description:

Breast cancer is the most commonly diagnosed malignant disease and the leading cause of cancer-related mortality among women.

Zoledronate is a bone-targeted bisphosphonate, which is used to treat osteoporosis and to reduce the risk of skeletal morbidity in patients with bone metastases. Zoledronate can also reduce the persistence of disseminated tumour cells in the bone marrow of women with early-stage breast cancer. Nowadays, consensus is emerging that certain subsets of patients with early-stage breast cancer may benefit from bisphosphonate therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female, age > 18.
  • Postoperative breast cancer patients who have finished adjuvant chemotherapy or unwilling to receive chemotherapy.
  • T score < -2.0, or -2.0 < T score <-1.0 with any 2 of the following risk factors: T score < -1.5, age > 65, BMI < 20kg/m^2, family history of hip fractures, age > 50 with brittle fracture history, oral steroid therapy > 6 months, receiving aromatase therapy.
  • ECOG(Eastern Cooperative Oncology Group) physical state score:0-2.
  • Breast cancer stage I-III confirmed by histological or cytological examination.
  • Patients received radical surgery with estimated survival time > 12 months.
  • Laboratory tests should be performed 1 week before enrollment and the results should meet the following criteria: neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 100×10^9/L, hemoglobin ≥ 80g/L, serum bilirubin ≤ 1.0×ULN, AST and ALT ≤ 1.5×ULN, Serum creatinine ≤ 1.0×ULN.
  • Patients who never received intravenous bisphosphonate within 12 months before enrollment and did not receive oral bisphosphonate within 3 weeks before enrollment.
  • Informed consents should be signed by the participants or their guardians. All the participants should be aware of the purpose and procedure of this study and willing to participate in this study.
  • Contraception required for those reproductive-aged women.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Patients who have not signed informed consent.
  • Patients received medical treatment which can affect bone metabolism (such as calcitonin, mithramycin or gallium nitrate) within 2 weeks before enrollment.
  • Bone metabolic diseases such as Paget's disease, epiphyseal dysplasia and primary or secondary hyperthyroidism diagnosed within 12 months before enrollment.
  • Liver function impairment which is defined as 2.5-fold or more increase in ALT or AST levels compared with the upper limit of reference range.
  • Refuse appropriate contraception (appropriate contraceptive options include female sterilisation, intrauterine device, oral contraceptives and barrier contraception).
  • Active dental diseases including dental infection, mandibular pain and maxillary or mandibular trauma. Patients with mandibular osteonecrosis diagnosed currently or previously, exposed bone or slow healing after oral surgery. Patients who will receive dental or maxillofacial surgery (such as dental extraction and dental implant) in the first 6 weeks after enrollment.
  • Patients with dysgnosia or communication disorder who can't well understand our study, cooperate with our staff or operate glucose monitor correctly.
  • Combined with major organ dysfunction or other severe diseases such as severe coronary disease, cardiovascular disease, myocardial infarction occurred within 12 months before enrollment, severe neurological or psychiatric diseases, severe infection or active disseminated intravascular coagulation.
  • Alcoholics or drug addicts.
  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: NCT01623908

Contacts
Contact: Ying Lin +86-20-87755766-8198 frostlin@hotmail.com

Locations
China, Guangdong
Dongguan People's Hospital Recruiting
Dongguan, Guangdong, China, 523059
Contact: Ailing Zhang         
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xuerui Li         
GuangDong Hospital Of Traditional Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Qianjun Chen         
General Hospital of Guangzhou Military Command of PLA Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Chenfang Zhang         
Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Donggeng Liu         
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Ning Liao       drliao_ning@hotmail.com   
Nanfang Hospital Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Jianming Xie         
Guangzhou First Municipal People's Hospital Recruiting
Guangzhou, Guangdong, China, 510180
Contact: Li Zhao         
The First Affiliated Hospital of Jinan University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Ningxia Wang         
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Erwei Song       songerwei02@yahoo.com.cn   
Shenzhen Second Municipal People's Hospital Recruiting
Shenzhen, Guangdong, China
Contact: Xianming Wang         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Chair: Shenming Wang, MD, PhD First Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Ying Lin, MD, PhD First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Ying Lin, Associate Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01623908     History of Changes
Other Study ID Numbers: 20110618GD
Study First Received: June 16, 2012
Last Updated: October 17, 2012
Health Authority: China: Ethics Committee

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
Breast neoplasms
Zoledronate
Bone loss

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014