Evaluating Incadronate for Breast Cancer with Bone Metastases

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

This study is testing if incadronate can help people with breast cancer that has spread to their bones feel better and stay safe while using the treatment.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06392217 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the efficacy and safety of incadronate in patients suffering from breast cancer with bone metastases. It involves real-world data collection from participants who meet specific eligibility criteria, including confirmed breast cancer and bone metastases. The study will monitor the outcomes of treatment with incadronate, focusing on both its effectiveness and any potential side effects experienced by the patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed breast cancer and imaging-confirmed bone metastases.

Not a fit: Patients who are pregnant or lactating, or those with serious concurrent diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for breast cancer patients with bone metastases, potentially improving their quality of life and treatment outcomes.

How similar studies have performed: While this study focuses on a specific treatment approach, similar studies evaluating bisphosphonates for bone metastases in breast cancer have shown promising results.

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.

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Jian Zhang

Conditions Breast Cancer; Bone Metastases