- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04098640
Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer
Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)
Breast cancer is the most common cancer in women worldwide, especially in developed countries. In developing countries, including South Korea, the incidence and mortality rate of breast cancer is rapidly increasing. One of the most important characteristics of breast cancer in South Korea, as well as in other Asian countries, is the younger onset of disease compared to Western.
Medical treatment of breast cancer is evolving rapidly, incorporating immune checkpoint blockades and molecularly targeted agents. However, data and knowledge are still limited in terms of molecular characteristics of Asian breast cancer, compared to that of Western countries, and this remains a major hurdle for drug development in Asian breast cancer patients.
The primary objective of this study is to elucidate the genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer using FoundationOne CDx.
Studieoversigt
Detaljeret beskrivelse
Secondary Objective(s):
- To evaluate the prognostic and predictive role of tumor mutation burden.
- To reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins (including DNA damage repair (DDR) molecules and various immune modulating molecules including PD-L1, PD-1, IDO, and OX40).
- Compare molecular characteristics of breast cancer according to age groups (<35 years vs. 35-50 years).
- To offer genomic profiling guided therapy to patients as early as possible (preferably, 1st- or 2nd-line of treatment). In addition, to explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Seoul, Korea, Republikken, 110-744
- Seoul National University Hospital
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients between 19 - 50 years of age on the day of signing informed consent.
- Able to provide written informed consent for voluntary participation in the trial.
- With metastatic breast cancer
- Willing to provide biopsies from the primary tumor or lymph nodes at screening to the central laboratory. (with at least 10 unstained slides and 1 H&E slide)
Exclusion Criteria:
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: FMI
FoundationOne CDx will be performed using archival tumor tissue
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FoundationOne CDx will be performed using archival tumor tissue
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.
Tidsramme: After the end of patient enrollment
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Genetic characteristics will be evaluated using FoundationOne CDx.
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After the end of patient enrollment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Evaluate the prognostic and predictive role of tumor mutation burden
Tidsramme: After the end of patient enrollment
|
Tumor mutation burden will be analysed using FoundationOne CDx.
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After the end of patient enrollment
|
Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins.
Tidsramme: After the end of patient enrollment
|
FoundationOne CDx results and immunohistochemical expression will be analysed.
|
After the end of patient enrollment
|
Compare molecular characteristics of breast cancer according to age groups.
Tidsramme: After the end of patient enrollment
|
Genetic characteristics will be analysed according to age groups.
|
After the end of patient enrollment
|
To offer genomic profiling guided therapy to patients To explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).
Tidsramme: After the end of patient enrollment
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The result of FoundationOne CDx will be used in patient treatment
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After the end of patient enrollment
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Seock-Ah Im, MD PhD, Seoul National University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SNUH_FMI
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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