clinIcal Efficacy and Safety of Incadronate in Breast Cancer With Bone Metastases

Breast Cancer Clinical Trial

Official title:

Real-world Study of Incadronate in Breast Cancer Patients With Metastatic Bone Disease: clinIcal Efficacy and Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392217
• Other study ID #: RELIEF
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Bone Metastases
• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis

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