Genetic Characteristics of HER2 Positive Breast Cancer With Neoadjuvant TCHP Chemotherapy

NCT ID: NCT04276337

Last Updated: 2020-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2023-08-31

Brief Summary

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Locally advanced breast cancer (LABC) is defined as breast cancer (BC) larger than 5 centimeters or with lymph node metastasis. Usually, LABC is treated with neoadjuvant chemotherapy (NAC) followed by curative surgery to reduce tumor size and eliminate micrometastasis. Response to NAC helps predict BC prognosis. Pathologic complete response (pCR), defined as no residual tumor cells after NAC, represents prolonged survival without BC recurrence and residual cancer burden score, based on residual tumor volume, and can more accurately predict BC outcomes. Especially, Human epidermal growth factor receptoor type 2(HER2)-positive breast cancer, having aggressive biologic characteristics, was mostly treated by NAC because of recent advance of highly effective targeted agents (pertuzumab and trastuzumab). However, still 30-40% of HER2-positive breast cancer did not response to NAC and underwent disease recurrence. Recently, genetic studies to find biomarker of BC prognosis have been widely performed. Circulating tumor DNA (ctDNA), which is circulating free DNA in the blood that originates from cancers, can be detected by recently-developed technologies. CtDNA could facilitate early disease detection, diagnosis and detection of disease recurrence. CtDNA also provides a genomic profile of BC and predicts drug response. In BC, ctDNA correlates with tumor burden and provides early detection of treatment response and tumor genetic alterations.

In this study, the investigator aimed to identify the correlations in genomic profile between tumors and ctDNA during NAC(docetaxel /carboplatin /trastuzumab and pertuzumab) in HER2 positive breast cancer.

Detailed Description

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Conditions

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HER2-positive Breast Cancer Chemotherapy Effect Circulating Tumor DNA

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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LiquidSCAN(Trade Mark) / CancerSCAN(Trade Mark)

LiquidSCAN : detection of circulating DNA CancerSCAN : detection of somatic mutation using tumor tissue

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* HER2+ Breast cancer
* Stage IIA - IIIC
* Plan to receive neoadjuvant chemotherapy with docetaxel, carboplatin, herceptin, perjeta
* Sign to informed consent

Exclusion Criteria

* Double primary cancer
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yeon Hee Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2018-01-054

Identifier Type: -

Identifier Source: org_study_id

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