Breast CancerNCT06392217
clinIcal Efficacy and Safety of Incadronate in Breast Cancer With Bone Metastases
An observational study of Breast Cancer and Bone Metastases, run by Fudan University at 1 site in China.
Trial summary
This is a real-world study to explore the efficacy and safety of incadronate in the treatment of breast cancer patients with bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Bone Metastases
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2024to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: breast cancer patients with bone metastases
Who may be able to join
- Male or female aged 18 years or above;
- Can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent
- The physical status score of the Eastern Cooperative Oncology Group (ECOG) was ≤3;
- Histologically or cytologically confirmed breast cancer;
- Imaging or histocytology confirmed bone metastases;
- There were indications of useing Incadronate and no contraindications in the use of Incadronate;
- New York Heart Association（NYHA）cardiac function grade ≤II, No serious heart disease;
- All women of childbearing age, fertile men or their spouses did not plan to have children or donate sperm throughout the trial period until 6 months after the last dose, or voluntarily took effective contraceptive measures.
Who cannot join
- Pregnant or lactating women;
- Patients with acute and chronic infections, or with other serious diseases at the same time, were judged not suitable for this study;
- Other malignant tumors within 5 years (except the following cases: cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma; A second primary cancer that has been eradicated and has not recurred within five years; Investigators have identified the primary tumor source of the metastases);
- Mental illness or mental disorder, poor compliance can not cooperate with and describe treatment response;
- There are serious organic diseases or major organ failure, such as decompensated heart, lung, liver, kidney failure, which can not tolerate treatment;
- Patients with bleeding tendency;
- The researcher believes that the patient has other conditions that are not suitable for participating in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University
Shanghai, Shanghai Municipality, 200032
Yuxin Mu, 34778299
About this study
Official title: Real-world Study of Incadronate in Breast Cancer Patients With Metastatic Bone Disease: clinIcal Efficacy and Safety
This is a real-world study to explore the efficacy and safety of incadronate in the treatment of breast cancer patients with bone metastases.
- Conditions
- Breast Cancer, Bone Metastases
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who had at least one Skeletal-related event（SRE）
The proportion of patients who had at least one SRE within 12 months after initial treatment with infadronate (including pathological fractures, spinal cord compression, radiotherapy or surgery for bone metastases);
Measured: 12 months
the time to first SRE
The time from the first treatment with infadronate to the first observation of any SRE
Measured: 12 months
Adverse events
Incidence and classification of various adverse events of infadronate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start12 Mar 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392217
- Sponsor's protocol ID
- RELIEF
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study of Incadronate in Breast Cancer Patients With Metastatic Bone Disease: clinIcal Efficacy and Safety
- ClinicalTrials.gov ID
- NCT06392217
- Acronym / sponsor ID
- RELIEF
- Conditions
- Breast Cancer, Bone Metastases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 30 Apr 2024 (actual)
- 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.
This is a real-world study to explore the efficacy and safety of incadronate in the treatment of breast cancer patients with bone metastases.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer patients with bone metastases
Key inclusion criteria (8 listed)
- Male or female aged 18 years or above;
- Can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent
- The physical status score of the Eastern Cooperative Oncology Group (ECOG) was ≤3;
- Histologically or cytologically confirmed breast cancer;
- Imaging or histocytology confirmed bone metastases;
Key exclusion criteria (7 listed)
- Pregnant or lactating women;
- Patients with acute and chronic infections, or with other serious diseases at the same time, were judged not suitable for this study;
- Other malignant tumors within 5 years (except the following cases: cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma; A second primary cancer that has been eradicated and has not recurred within five years; Investigators have identified the primary tumor source of the metastases);
- Mental illness or mental disorder, poor compliance can not cooperate with and describe treatment response;
- There are serious organic diseases or major organ failure, such as decompensated heart, lung, liver, kidney failure, which can not tolerate treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients who had at least one Skeletal-related event（SRE）
Time frame: 12 months
The proportion of patients who had at least one SRE within 12 months after initial treatment with infadronate (including pathological fractures, spinal cord compression, radiotherapy or surgery for bone metastases);
the time to first SRE
Time frame: 12 months
The time from the first treatment with infadronate to the first observation of any SRE
Adverse events
Time frame: 12 months
Incidence and classification of various adverse events of infadronate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Bone Metastases, run by Fudan University at 1 site 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang (+8664175590, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who had at least one Skeletal-related event（SRE） (time frame: 12 months). The study lists 3 primary outcomes in all. 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 2 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.