Genetic Characteristics of HER2 Positive Breast Cancer With Neoadjuvant TCHP Chemotherapy

February 18, 2020 updated by: Yeon Hee Park, Samsung Medical Center

Genetic Characteristics of HER2 Positive Breast Cancer Receiving Neoadjuvant Chemotherapy With Docetaxel, Carboplatin, Trastuzumab and Pertuzumab (TCHP) Regimen

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Locally advanced HER2 positive breast cancer receiving neoadjuvant chemotherapy with docetaxel, carboplatin, trastuzumab and pertuzumab (TCHP) regimen

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathologic complete response
Time Frame: Pathologic Clinical response is performed after end of cycle 6 (each cycle is 21 days)
pCR of neoadjuvant(TCHP) chemotherapy with the patients with HER2 positive BC.
Pathologic Clinical response is performed after end of cycle 6 (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ANTICIPATED)

April 30, 2020

Study Completion (ANTICIPATED)

August 31, 2023

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (ACTUAL)

February 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01-054

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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