Clinical trial NCT04098640: Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer
Official title: Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer
Keywords: Young patient
Asian
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

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.

Primary outcomes:
measure: Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.
timeFrame: After the end of patient enrollment
Secondary outcomes:
measure: Evaluate the prognostic and predictive role of tumor mutation burden
timeFrame: After the end of patient enrollment
measure: Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins.
timeFrame: After the end of patient enrollment
measure: Compare molecular characteristics of breast cancer according to age groups.
timeFrame: After the end of patient enrollment
measure: 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).
timeFrame: After the end of patient enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seock-Ah Im, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: