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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06392217
Other study ID # RELIEF
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 12, 2024
Est. completion date April 1, 2026

Study information

Verified date April 2024
Source Fudan University
Contact Jian Zhang
Phone +8664175590
Email syner2000@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date April 1, 2026
Est. primary completion date April 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
China Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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); 12 months
Primary the time to first SRE The time from the first treatment with infadronate to the first observation of any SRE 12 months
Primary Adverse events Incidence and classification of various adverse events of infadronate 12 months
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