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

NCT06392217 | Recruiting DMC

• 1 other identifier: RELIEF
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Bone Metastases

Outcome Measures

Primary Outcomes (3)

• 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

• the time to first SRE

  The time from the first treatment with infadronate to the first observation of any SRE

  12 months

• Adverse events

  Incidence and classification of various adverse events of infadronate

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

breast cancer patients with bone metastases

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jian Zhang

CONTACT

+8664175590; syner2000@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 30, 2024
• Study Start: March 12, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)