Epidemiology of TNBC in Asyut Clinical Oncology Department

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05586659
• Lead Sponsor: Assiut University

Brief Summary

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 Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-15
• Study First Submitted QC: 2022-10-15
• Last Update Submitted: 2022-10-15
• Study First Posted: 2022-10-19
• Last Update Posted: 2022-10-19
• Study Start: 2022-11-01
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of TNBC	Baseline	Incidence of TNBC in clinical oncology department from 2015-2022
Behavior of the disease and stage	baseline	Behavior of the disease and stage of presentation
Types of treatment	baseline	Types of treatment

Secondary Outcome Measures

Name	Time	Method
DFS	Baseline	Disease free survival
OS	Baseline	overall survival
PFS	Baseline	progression free survival