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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04098640
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 9.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Genetic: FoundationOne CDx	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)
• Anticipated Study Start Date: Sep 1, 2019
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: FMI FoundationOne CDx will be performed using archival tumor tissue	Genetic: FoundationOne CDx; FoundationOne CDx will be performed using archival tumor tissue

Outcome Measures

Primary Outcome Measures

1. Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer. [After the end of patient enrollment]

   Genetic characteristics will be evaluated using FoundationOne CDx.

Secondary Outcome Measures

1. Evaluate the prognostic and predictive role of tumor mutation burden [After the end of patient enrollment]

   Tumor mutation burden will be analysed using FoundationOne CDx.

2. Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins. [After the end of patient enrollment]

   FoundationOne CDx results and immunohistochemical expression will be analysed.

3. Compare molecular characteristics of breast cancer according to age groups. [After the end of patient enrollment]

   Genetic characteristics will be analysed according to age groups.

4. 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). [After the end of patient enrollment]

   The result of FoundationOne CDx will be used in patient treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Seock-Ah Im, MD PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seock-Ah Im, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04098640
• Other Study ID Numbers: SNUH_FMI
• First Posted: Sep 23, 2019
• Last Update Posted: Sep 23, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seock-Ah Im, Professor, Seoul National University Hospital: Young patient; Asian
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 23, 2019