Genetic Alteration After Systemic Treatment in Breast Cancer

NCT02591966 | Unknown

• 1 other identifier: 2014-11-015
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Biomarker group

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:

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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:

You may qualify if:

• Patients older than 20 years
• 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.
• Patients with PS ECOG 0 - 2
• Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
• Written informed consent form
• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood sample : whole blood 2. Tissue : Fresh tissue, Fixed tissue (5ea of 5-10µm unstained sections),

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yeon Hee Park, MD, PH.D

CONTACT

82-2-3410-3459; yeonh.park@samsung.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Division of Hematology-Oncology

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 30, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

KR (1)