NCT06723132

Brief Summary

The aim of the study is to to describe the pattern of BM in breast cancer patients, assess the prognostic significance of patient related-factors and to evaluate the efficacy of various treatment modalities. clinicopathological factors and prognostic factors that affect the occurrence of brain metastases and which factors affect the survival after the occurrence of brain metastases remain to be identified . This may help identify patients at high risk for brain metastases and patients with poor prognosis after brain metastases, thus providing them with some preventive or therapeutic measures.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jan 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Feb 2027

First Submitted

Initial submission to the registry

December 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 4, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

prognostic factors

Outcome Measures

Primary Outcomes (1)

  • overall survival time

    Time from brain metasets diagnosis till death.

    baseline

Study Arms (1)

breast cancer

breast cancer patients with -Radiological documentation of BM by computed tomography (CT) OR magnetic resonance imaging (MRI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

breast cancer patients with brain metasets

You may qualify if:

  • Age \>18
  • Histological proven breast cancer
  • Radiological documentation of BM by computed tomography (CT) OR magnetic resonance imaging (MRI)
  • Patients who had been followed up for at least 6 months.

You may not qualify if:

  • Not histologically proven Breast cancer
  • Patient without full medical data
  • Those with previous or concurrent diagnosis of second primary malignancy
  • Patients with leptomeningeal or dural metastases without co-existent parenchymal metastatic lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yamamoto M, Serizawa T, Higuchi Y, Sato Y, Kawagishi J, Yamanaka K, Shuto T, Akabane A, Jokura H, Yomo S, Nagano O, Aoyama H. A Multi-institutional Prospective Observational Study of Stereotactic Radiosurgery for Patients With Multiple Brain Metastases (JLGK0901 Study Update): Irradiation-related Complications and Long-term Maintenance of Mini-Mental State Examination Scores. Int J Radiat Oncol Biol Phys. 2017 Sep 1;99(1):31-40. doi: 10.1016/j.ijrobp.2017.04.037. Epub 2017 Aug 7.

    PMID: 28816158BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Huda Thabet Mohamed, resident doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at Clinical oncology department

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 9, 2024

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

December 9, 2024

Record last verified: 2024-12