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

Recruiting

• Conditions: Breast Cancer; Bone Metastases

• Registration Number: NCT06392217
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-12
• Study First Submitted: 2024-03-27
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-27
• Last Update Submitted: 2024-04-27
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the time to first SRE	12 months	The time from the first treatment with infadronate to the first observation of any SRE
The proportion of patients who had at least one Skeletal-related event（SRE）	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);
Adverse events	12 months	Incidence and classification of various adverse events of infadronate

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University; 🇨🇳 Shanghai, Shanghai, China