BLAZE: Bone Loss Treatment From Adjuvant Zoledronate Efficacy

Sponsor

First Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Terminated

CT.gov ID

NCT01623908

Collaborator

(none)

200

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Breast Neoplasms Bone Loss	Drug: Zoledronate	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open,Multicentre,Prospective Study of Adjuvant Zoledronate Treatment in Osteoporosis Women With Breast Cancer

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Zometa

Arm

Intervention/Treatment

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 Names:

Zometa

Outcome Measures

Primary Outcome Measures

Change from Baseline in Bone Mineral Density [48 weeks]

Secondary Outcome Measures

Bone metastasis rate [From date of randomization until the date of bone metastasis, assessed up to 48 weeks.]
Disease-Free Survival [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Dongguan People's Hospital	Dongguan	Guangdong	China	523059
2	General Hospital of Guangzhou Military Command of PLA	Guangzhou	Guangdong	China	510010
3	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong	China	510060
4	Guangdong General Hospital	Guangzhou	Guangdong	China	510080
5	GuangDong Hospital Of Traditional Chinese Medicine	Guangzhou	Guangdong	China	510120
6	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510120
7	Guangzhou First Municipal People's Hospital	Guangzhou	Guangdong	China	510180
8	Nanfang Hospital	Guangzhou	Guangdong	China	510515
9	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong	China	510630
10	Shenzhen Second Municipal People's Hospital	Shenzhen	Guangdong	China

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