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

Launched by FUDAN UNIVERSITY · Apr 27, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a medication called incadronate for patients with breast cancer that has spread to the bones, known as bone metastases. The study is currently looking for participants who are at least 18 years old and can understand the purpose of the trial. Eligible participants must have a confirmed diagnosis of breast cancer and evidence of bone metastases, as well as a good overall health status that allows them to participate in the study.

If someone decides to take part in this trial, they can expect to receive incadronate and be monitored for its effects on their condition. It's important to note that women who are pregnant or breastfeeding, as well as those with certain serious health issues, may not be able to participate. The trial aims to provide valuable information that could help improve treatment options for breast cancer patients experiencing bone metastases.

Gender

ALL

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.