C50.9
Conditions
Interventions
Group 1: Retrospective study of humoral and cellular B-cell immune responses in patients of the investigators own institution diagnosed with DCIS (n=40) or early breast cancer (n=40) between 2010 and
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Completeness of EMR/KIS records for clinic-pathologic and demographic data • Availability of treatment naïve, representative core needle biopsy or surgically resected tissue; sTILs = 10% (ITWG) • DCIS: Histologically confirmed diagnosis of DCIS (pTis pN0 cM0), • EBC: Histologically confirmed diagnosis of invasive breast cancer of no special type (NST) • MBC: Histologically confirmed diagnosis of inoperable, locally advanced or metastatic breast cancer of no special type (NST), treatment with ICB (Atezolizumab or Pembrolizumab) according to standard of care. Monotherapy OR combination with chemotherapy OR combination with targeted therapy. • Complete follow up of = 5 years, in line with standard of care guidelines • Known ER, PR, HER2 Status
Exclusion criteria
Exclusion criteria: • Any other history of neoplasms • Inflammatory breast cancer • Metaplastic breast cancer • Known current or past treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL] -2) • Known history of autoimmune disease prior to the diagnosis of breast cancer, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. (Patients with autoimmune-related hypothyroidism are permitted) • History of HIV infection • History of tuberculosis • History diagnosis of invasive breast associated with pregnancy or puerperium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aggregation of demographically and biologically representative cohorts in patients with DCIS, EBC, and MBC by pairing demographic and clinico-pathological parameters. Quantitative-descriptive characterization of B-lymphocyte infiltration into the microenvironment and their (co-)localization with other immune and tumor cells (DCIS, EBC, MBC). Quantitative-descriptive characterization of the occurrence of aggregates and tertiary lymphoid structures (TLS) (DCIS, EBC, MBC). Identification of differentially expressed genes and gene sets in relation to clinical and pathological variables, particularly regarding prognosis (DCIS, EBC, MBC) and response to immunotherapy (MBC). Correlation and spatial-functional analysis of protein expression on B-lymphocytes using multiplex immunofluorescence (mIF) | — |
Countries
Germany
Contacts
Public ContactCarlo Fremd
Universitätsklinikum Heidelberg
Outcome results
None listed