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RecruitingNCT06392217

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

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

Sponsor

Fudan University

Enrollment

500 participants

Start Date

Mar 12, 2024

Study Type

OBSERVATIONAL

Conditions

Breast CancerBone Metastases

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Male or female aged 18 years or above;
  • Can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent
  • The physical status score of the Eastern Cooperative Oncology Group (ECOG) was ≤3;
  • Histologically or cytologically confirmed breast cancer;
  • Imaging or histocytology confirmed bone metastases;
  • There were indications of useing Incadronate and no contraindications in the use of Incadronate;
  • New York Heart Association（NYHA）cardiac function grade ≤II, No serious heart disease;
  • 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 Criteria7

  • Pregnant or lactating women;
  • Patients with acute and chronic infections, or with other serious diseases at the same time, were judged not suitable for this study;
  • 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);
  • Mental illness or mental disorder, poor compliance can not cooperate with and describe treatment response;
  • There are serious organic diseases or major organ failure, such as decompensated heart, lung, liver, kidney failure, which can not tolerate treatment;
  • Patients with bleeding tendency;
  • The researcher believes that the patient has other conditions that are not suitable for participating in this study.

Locations(1)

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

Shanghai, Shanghai Municipality, China

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NCT06392217

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