Genetic Alteration After Systemic Treatment in Breast Cancer

The purpose of this study is to investigate effects of systemic treatments on genomic profiles in patients with breast cancer and to compare genomic profiling between premenopausal and postmenopausal women by systemic treatments in breast cancer.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer

Detailed Description

Prospective single arm trial using three patients' cohorts. One-hundred patients for each cohort and a total of 300 patients (600 biopsy samples) will be entered to this trial.

The hypothesis is that genomic alterations measured by CancerSCAN and cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be different between pre- and post-menopausal women and would be predictive biomarkers for each cohort according to pre- and post-menopausal status. Three groups of patients will be recruited:

1. The patients who receive neoadjuvant systemic treatments:
2. The patients who have distant metastatic sites at first and recur from surgery:
3. The patients who are going to receive first-line chemotherapy

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Yeon Hee Park, MD, Ph.D; Phone Number: 82-2-3410-3459; Email: yeonh.park@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

1. The patients who receive neoadjuvant systemic treatments:
2. The patients who have distant metastatic sites at first and recur from surgery:
3. The patients who are going to receive first-line chemotherapy:

Description

Inclusion Criteria:

1. Patients older than 20 years

2. Patients with histologically confirmed breast cancer at three disease status

   • Patients who are going to receive neoadjuvant chemotherapy with feasible biopsy site.
   • Patients who recur from curative surgery and have distant metastasis with feasible biopsy site. ; Patients must have received adjuvant chemotherapy after curative surgery.
   • Patients who are going to first-line palliative chemotherapy with feasible biopsy site.
3. Patients with PS ECOG 0 - 2
4. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
5. Written informed consent form

6. Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to study as defined below:

   • Haemoglobin ≥9.0 g/L (transfusion allowed)
   • White blood cells (WBC) > 3 x 109/L
   • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
   • AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN

Exclusion Criteria:

1. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.
2. Double primary cancer (except for any cancer in remission for > 5 years, cervix cancer in situ, basal cell cancer in situ, any in situ cancers that are resected)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Biomarker group; The patients who receive neoadjuvant systemic treatments:; The patients who have distant metastatic sites at first and recur from surgery:; The patients who are going to receive first-line chemotherapy:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genomic profiling will be assessed by tissue sampling and blood.	Tissue and blood will be tested for CancerSCAN, cfDNA, WES, WTS, FACS, cytokine and immunologic signature analysis platform.NAC to study the multiscale relationships among DCE-MRI features, NGS data, and pathologic response to NAC and to evaluate the role of radiogenomics in predicting pathologic response of the patients.	2year

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2014-11-015