Breast CancerNCT06723132
A Retrospective Study of Prognostic Factors and Survival of Breast Cancer Patients With Brain Metastesis
An observational study of Breast Cancer, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: breast cancer patients with brain metasets
Who may be able to join
- -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.
Who cannot join
- -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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Breast cancer (BC) has become the malignancy with the highest morbidity rate in women. Despite significant advances in the diagnosis and treatment of breast cancer, metastasis is still an important factor that seriously affects patients' quality of life and prognosis. It has been reported that distant metastases have been found at the initial diagnosis of breast cancer in about 6-10% of patients The bones, lungs, liver and brain are the four most common distant metastatic sites of breast cancer Compared with bone metastases and visceral metastases, patients with brain metastases have significantly worse prognosis The median time from diagnosis of breast cancer to CNS metastasis has been reported to be 33 month The survival of these patients may be affected by factors including molecular subtypes, performance status, ressectability of BM and visceral metastasis burden. When detected, its treatment is usually difficult and unfortunately has reverse effects on life expectancy Multi-disciplinary therapy (MDT) is the first choice for the treatment of brain metastases in breast cancer MDT for breast cancer brain metastasis includes surgery, whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS), chemotherapy, endocrine therapy, targeted therapy, etc. For patients with multiple brain metastases and neurological symptoms, WBRT combined with palliative care is the preferred option In general, patients with brain metastases of 3 or less were recommended to receive surgical resection. Patients with 4 to 5 brain metastases but less 3cm in diameter can undergo SRS .
- Conditions
- Breast Cancer
- Keywords
- prognostic factors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer | breast cancer patients with -Radiological documentation of BM by computed tomography (CT) OR magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival time
Time from brain metasets diagnosis till death.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Abdelsamee Thabet Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723132
- Sponsor's protocol ID
- prognostic factors+survival BC
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28816158
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Prognostic Factors and Survival of Breast Cancer Patients With Brain Metastesis
- ClinicalTrials.gov ID
- NCT06723132
- Acronym / sponsor ID
- prognostic factors+survival BC
- Conditions
- Breast Cancer
- Keywords
- prognostic factors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer (BC) has become the malignancy with the highest morbidity rate in women. Despite significant advances in the diagnosis and treatment of breast cancer, metastasis is still an important factor that seriously affects patients' quality of life and prognosis. It has been reported that distant metastases have been found at the initial diagnosis of breast cancer in about 6-10% of patients The bones, lungs, liver and brain are the four most common distant metastatic sites of breast cancer Compared with bone metastases and visceral metastases, patients with brain metastases have significantly worse prognosis The median time from diagnosis of breast cancer to CNS metastasis has been reported to be 33 month The survival of these patients may be affected by factors including molecular subtypes, performance status, ressectability of BM and visceral metastasis burden. When detected, its treatment is usually difficult and unfortunately has reverse effects on life expectancy Multi-disciplinary therapy (MDT) is the first choice for the treatment of brain metastases in breast cancer MDT for breast cancer brain metastasis includes surgery, whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS), chemotherapy, endocrine therapy, targeted therapy, etc. For patients with multiple brain metastases and neurological symptoms, WBRT combined with palliative care is the preferred option In general, patients with brain metastases of 3 or less were recommended to receive surgical resection. Patients with 4 to 5 brain metastases but less 3cm in diameter can undergo SRS .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer | – | –breast cancer patients with -Radiological documentation of BM by computed tomography (CT) OR magnetic resonance imaging (MRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer patients with brain metasets
Key inclusion criteria (4 listed)
- -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.
Key exclusion criteria (4 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival time
Time frame: baseline
Time from brain metasets diagnosis till death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Results publication: PubMed 28816158Yamamoto 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huda Thabet Mohamed, resident doctor (+201152476153, huda.abdelsamee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival time (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06723132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.