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

April 27, 2024 updated by: Jian Zhang,MD, Fudan University

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

This is a real-world study to explore the efficacy and safety of incadronate in the treatment of breast cancer patients with bone metastases.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University
        • Contact:
          • Yuxin Mu
          • Phone Number: 34778299

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

breast cancer patients with bone metastases

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

April 27, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 27, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RELIEF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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