Breast NeoplasmsBLAZENCT01623908
Bone Loss Treatment From Adjuvant Zoledronate Efficacy
A study testing Zoledronate in people with Breast Neoplasms and Bone Loss, run by First Affiliated Hospital, Sun Yat-Sen University at 10 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Bone Loss
- What is being tested?
- Zoledronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 sitesChina
- Study dates
- Jul 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Dongguan People's Hospital
Dongguan, Guangdong, 523059
General Hospital of Guangzhou Military Command of PLA
Guangzhou, Guangdong, 510010
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Guangdong General Hospital
Guangzhou, Guangdong, 510080
GuangDong Hospital Of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, 510180
Nanfang Hospital
Guangzhou, Guangdong, 510515
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
Shenzhen Second Municipal People's Hospital
Shenzhen, Guangdong
About this study
Official title: An Open,Multicentre,Prospective Study of Adjuvant Zoledronate Treatment in Osteoporosis Women With Breast Cancer
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
Read the 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.
- Conditions
- Breast Neoplasms, Bone Loss
- Being tested
- Zoledronate
- Keywords
- Breast neoplasms, Zoledronate, Bone loss
- Medical subject headings
- Breast Neoplasms, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoledronateDrug
Also called Zometa
4mg, IV (in the vein) every 6 months. Number of Cycles: up to the researcher or until unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| Zoledronate | Experimental | Not described Receives: Drug: Zoledronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Bone Mineral Density
Measured: 48 weeks
Secondary outcomes (2)
Bone metastasis rate
Measured: From date of randomization until the date of bone metastasis, assessed up to 48 weeks.
Disease-Free Survival
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJul 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Lin, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Shenming Wang, MD, PhD, Study chair, First Affiliated Hospital, Sun Yat-Sen UniversityYing Lin, MD, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623908
- Sponsor's protocol ID
- 20110618GD
- Acronym
- BLAZE
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2012
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open,Multicentre,Prospective Study of Adjuvant Zoledronate Treatment in Osteoporosis Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT01623908
- Acronym / sponsor ID
- BLAZE / 20110618GD
- Conditions
- Breast Neoplasms, Bone Loss
- Keywords
- Breast neoplasms, Zoledronate, Bone loss
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zoledronate | Experimental | Drug: Zoledronate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZoledronateAlso: Zometa4mg, IV (in the vein) every 6 months. Number of Cycles: up to the researcher or until unacceptable toxicity develops. | Drug | Zoledronate |
Primary outcome
Change from Baseline in Bone Mineral Density
Time frame: 48 weeks
2 secondary outcomes
Bone metastasis rate
Time frame: From date of randomization until the date of bone metastasis, assessed up to 48 weeks.
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shenming Wang, MD, PhD study chair
First Affiliated Hospital, Sun Yat-Sen University
Ying Lin, MD, PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoledronate in people with Breast Neoplasms and Bone Loss, run by First Affiliated Hospital, Sun Yat-Sen University at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Bone Mineral Density (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021; AzTrials last refreshed its copy on 31 Oct 2026.