Epidemiology of TNBC in Asyut Clinical Oncology Department

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05586659
Collaborator
(none)
50
13

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Epidemiology of Triple Negative Breast Cancer in Asyut Clinical Oncology Department From 2015 to 2022 ( A Hospital Based Study)
    Anticipated Study Start Date :
    Nov 1, 2022
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of TNBC [Baseline]

      Incidence of TNBC in clinical oncology department from 2015-2022

    2. Behavior of the disease and stage [baseline]

      Behavior of the disease and stage of presentation

    3. Types of treatment [baseline]

      Types of treatment

    Secondary Outcome Measures

    1. DFS [Baseline]

      Disease free survival

    2. PFS [Baseline]

      progression free survival

    3. OS [Baseline]

      overall survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Aya Saber Khalifa Mohammed, Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05586659
    Other Study ID Numbers:
    • TNBC
    First Posted:
    Oct 19, 2022
    Last Update Posted:
    Oct 19, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2022