Genetic Characteristics of HER2 Positive Breast Cancer With Neoadjuvant TCHP Chemotherapy

HER2-positive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04276337
• Other study ID #: 2018-01-054
• Status: Active, not recruiting
• Start date: March 1, 2018
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 31, 2023
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Chemotherapy Effect
• Circulating Tumor DNA
• HER2-positive Breast Cancer

Intervention

Diagnostic Test:
• LiquidSCAN(Trade Mark) / CancerSCAN(Trade Mark)
LiquidSCAN : detection of circulating DNA CancerSCAN : detection of somatic mutation using tumor tissue

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response	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)