Epidemiology of TNBC in Asyut Clinical Oncology Department

October 15, 2022 updated by: Aya Saber Khalifa Mohammed, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

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 Contact Backup

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

male or female with triple negative breast cancer Diagnosed as TNBC from ( 2015- 2022 ) confirmed by pathology

- Adjuvant or metastatic

Description

Inclusion Criteria:- Age ≥ 18

  • Male or female
  • Diagnosed as TNBC from ( 2015- 2022 ) confirmed by pathology
  • Adjuvant or metastatic

Exclusion Criteria:- Have other type of malignancy

  • HER2 , ER, PR positive

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of TNBC
Time Frame: Baseline
Incidence of TNBC in clinical oncology department from 2015-2022
Baseline
Behavior of the disease and stage
Time Frame: baseline
Behavior of the disease and stage of presentation
baseline
Types of treatment
Time Frame: baseline
Types of treatment
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: Baseline
Disease free survival
Baseline
PFS
Time Frame: Baseline
progression free survival
Baseline
OS
Time Frame: Baseline
overall survival
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 15, 2022

First Submitted That Met QC Criteria

October 15, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 15, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNBC

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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