Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04098640
• Other study ID #: SNUH_FMI
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 2019
• Est. completion date: July 2021

Study information

• Verified date: September 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• FoundationOne CDx
FoundationOne CDx will be performed using archival tumor tissue

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer.	Genetic characteristics will be evaluated using FoundationOne CDx.	After the end of patient enrollment
Secondary	Evaluate the prognostic and predictive role of tumor mutation burden	Tumor mutation burden will be analysed using FoundationOne CDx.	After the end of patient enrollment
Secondary	Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins.	FoundationOne CDx results and immunohistochemical expression will be analysed.	After the end of patient enrollment
Secondary	Compare molecular characteristics of breast cancer according to age groups.	Genetic characteristics will be analysed according to age groups.	After the end of patient enrollment
Secondary	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).	The result of FoundationOne CDx will be used in patient treatment	After the end of patient enrollment