NCT06392217 clinIcal Efficacy and Safety of Incadronate in Breast Cancer With Bone Metastases
| NCT ID | NCT06392217 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-03-12 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female aged 18 years or above; 2. Can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent 3. The physical status score of the Eastern Cooperative Oncology Group (ECOG) was ≤3; 4. Histologically or cytologically confirmed breast cancer; 5. Imaging or histocytology confirmed bone metastases; 6. There were indications of useing Incadronate and no contraindications in the use of Incadronate; 7. New York Heart Association（NYHA）cardiac function grade ≤II, No serious heart disease; 8. 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. Exclusion Criteria: 1. Pregnant or lactating women; 2. Patients with acute and chronic infections, or with other serious diseases at the same time, were judged not suitable for this study; 3. 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); 4. Mental illness or mental disorder, poor compliance can not cooperate with and describe treatment response; 5. There are serious organic diseases or major organ failure, such as decompensated heart, lung, liver, kidney failure, which can not tolerate treatment; 6. Patients with bleeding tendency; 7. The researcher believes that the patient has other conditions that are not suitable for participating in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06392217 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06392217 currently recruiting?
Yes, NCT06392217 is actively recruiting participants. Contact the research team at syner2000@163.com for enrollment information.
Where is the NCT06392217 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06392217 clinical trial?
NCT06392217 is sponsored by Fudan University. The trial plans to enroll 500 participants.
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