Epidemiology of TNBC in Asyut Clinical Oncology Department

Breast Cancer Clinical Trial

Official title:

Epidemiology of Triple Negative Breast Cancer in Asyut Clinical Oncology Department From 2015 to 2022 ( A Hospital Based Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05586659
• Other study ID #: TNBC
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: Aya saber
• Phone: 01143980715
• Email: ayasaber171186[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Epidemiological Study about behavior of TNBC in Clinical oncology department in 8 y in Asyut university hospital

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Lin 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of TNBC	Incidence of TNBC in clinical oncology department from 2015-2022	Baseline
Primary	Behavior of the disease and stage	Behavior of the disease and stage of presentation	baseline
Primary	Types of treatment	Types of treatment	baseline
Secondary	DFS	Disease free survival	Baseline
Secondary	PFS	progression free survival	Baseline
Secondary	OS	overall survival	Baseline