Breast CancerNCT05586659
Epidemiology of TNBC in Asyut Clinical Oncology Department
An observational study of Breast Cancer, run by Assiut University.
Trial summary
Epidemiological Study about behavior of TNBC in Clinical oncology department in 8 y in Asyut university hospital Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: male or female with triple negative breast cancer Diagnosed as TNBC from ( 2015- 2022 ) confirmed by pathology - Adjuvant or metastatic
Who may be able to join
- Male or female
- Diagnosed as TNBC from ( 2015- 2022 ) confirmed by pathology
- Adjuvant or metastatic
Who cannot join
- HER2 , ER, PR positive
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Epidemiology of Triple Negative Breast Cancer in Asyut Clinical Oncology Department From 2015 to 2022 ( A Hospital Based Study)
Epidemiological Study about behavior of TNBC in Clinical oncology department in 8 y in Asyut university hospital
Read the detailed description
Breast Cancer )BC) is the most Common malignancy in women in 2020, there were 2.3 million women diagnosed with breast cancer and 685.000 deaths globally. Breast cancer rates are 88% higher in developed countries compared to developing countries .
TNBC represents accounts for approximately 24% of all breast cancer in 2020 .While in Egypt it accounts for 11.05% according to Egyptian national BC (5). By gene expression profiling ,4 subtypes of TNBC emerged : luminal androgen receptor (LAR), mesenchymal stem-like (MSL), immunomodulatory (IM), basal-like (BL1 and BL2) . Most of cases are advanced with median survival about 14 months . Brain and visceral organs represent common sites of distant metastasis . So it is considered the worst prognosis . In addition , chemotherapy is only option in treatment with no available targeted options for decades. Now we have Immunotherapy (IO ) and PARP inhibitors in neoadjuvant (NAT) and metastatic setting For example : Key note 355 which add Pembrolizumab in NAT which lead to marked improvement in pathological complete response ( PCR ) And in high risk patient and have marked results in disease and event free survival(8) .Poly (ADP-ribase) poly merase -1 (PARP-1) inhibitors appear to particularly effective in BRCA 1/2 mutation carries (9) .As reviewed by rodleret al. emerging data suggest that BRCA 1/2 carriers with TNBC disease may respond favorably to cisplatin therapy .
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TNBC
Incidence of TNBC in clinical oncology department from 2015-2022
Measured: Baseline
Behavior of the disease and stage
Behavior of the disease and stage of presentation
Measured: baseline
Types of treatment
Types of treatment
Measured: baseline
Secondary outcomes (3)
DFS
Disease free survival
Measured: Baseline
PFS
progression free survival
Measured: Baseline
OS
overall survival
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Saber Khalifa Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586659
- Sponsor's protocol ID
- TNBC
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013 Nov 1;31(31):3997-4013. doi: 10.1200/JCO.2013.50.9984. Epub 2013 Oct 7.
PubMed 24101045Lin NU, Claus E, Sohl J, Razzak AR, Arnaout A, Winer EP. Sites of distant recurrence and clinical outcomes in patients with metastatic triple-negative breast cancer: high incidence of central nervous system metastases. Cancer. 2008 Nov 15;113(10):2638-45. doi: 10.1002/cncr.23930.
PubMed 18833576
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Triple Negative Breast Cancer in Asyut Clinical Oncology Department From 2015 to 2022 ( A Hospital Based Study)
- ClinicalTrials.gov ID
- NCT05586659
- Acronym / sponsor ID
- TNBC
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Oct 2022 (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.
Epidemiological Study about behavior of TNBC in Clinical oncology department in 8 y in Asyut university hospital
Detailed description
Breast Cancer )BC) is the most Common malignancy in women in 2020, there were 2.3 million women diagnosed with breast cancer and 685.000 deaths globally. Breast cancer rates are 88% higher in developed countries compared to developing countries .
TNBC represents accounts for approximately 24% of all breast cancer in 2020 .While in Egypt it accounts for 11.05% according to Egyptian national BC (5). By gene expression profiling ,4 subtypes of TNBC emerged : luminal androgen receptor (LAR), mesenchymal stem-like (MSL), immunomodulatory (IM), basal-like (BL1 and BL2) . Most of cases are advanced with median survival about 14 months . Brain and visceral organs represent common sites of distant metastasis . So it is considered the worst prognosis . In addition , chemotherapy is only option in treatment with no available targeted options for decades. Now we have Immunotherapy (IO ) and PARP inhibitors in neoadjuvant (NAT) and metastatic setting For example : Key note 355 which add Pembrolizumab in NAT which lead to marked improvement in pathological complete response ( PCR ) And in high risk patient and have marked results in disease and event free survival(8) .Poly (ADP-ribase) poly merase -1 (PARP-1) inhibitors appear to particularly effective in BRCA 1/2 mutation carries (9) .As reviewed by rodleret al. emerging data suggest that BRCA 1/2 carriers with TNBC disease may respond favorably to cisplatin therapy .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- male or female with triple negative breast cancer Diagnosed as TNBC from ( 2015- 2022 ) confirmed by pathology - Adjuvant or metastatic
Key inclusion criteria (3 listed)
- Male or female
- Diagnosed as TNBC from ( 2015- 2022 ) confirmed by pathology
- Adjuvant or metastatic
Key exclusion criteria (1 listed)
- HER2 , ER, PR positive
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
Incidence of TNBC
Time frame: Baseline
Incidence of TNBC in clinical oncology department from 2015-2022
Behavior of the disease and stage
Time frame: baseline
Behavior of the disease and stage of presentation
Types of treatment
Time frame: baseline
Types of treatment
3 secondary outcomes
DFS
Time frame: Baseline
PFS
Time frame: Baseline
OS
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Background: PubMed 24101045Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013 Nov 1;31(31):3997-4013. doi: 10.1200/JCO.2013.50.9984. Epub 2013 Oct 7.
- Background: PubMed 18833576Lin NU, Claus E, Sohl J, Razzak AR, Arnaout A, Winer EP. Sites of distant recurrence and clinical outcomes in patients with metastatic triple-negative breast cancer: high incidence of central nervous system metastases. Cancer. 2008 Nov 15;113(10):2638-45. doi: 10.1002/cncr.23930.
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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. This study is not recruiting at the moment.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya saber (01143980715, ayasaber171186@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TNBC (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT05586659, which also lists 2 linked publications.
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 19 Oct 2022.