Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FoundationOne CDx.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 19 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)
Overview
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.
Detailed description
Secondary Objective(s):
1. To evaluate the prognostic and predictive role of tumor mutation burden. 2. 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). 3. Compare molecular characteristics of breast cancer according to age groups (\<35 years vs. 35-50 years). 4. 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).
Interventions
- Genetic FoundationOne CDx
FoundationOne CDx will be performed using archival tumor tissue
Primary outcome measures
- Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer. [Time frame: After the end of patient enrollment]
Secondary outcome measures (4)
- Evaluate the prognostic and predictive role of tumor mutation burden [Time frame: After the end of patient enrollment]
- Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins. [Time frame: After the end of patient enrollment]
- Compare molecular characteristics of breast cancer according to age groups. [Time frame: 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). [Time frame: After the end of patient enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT04098640 · SNUH_FMI