HER2-positive Breast CancerNCT04276337
Genetic Characteristics of HER2 Positive Breast Cancer With Neoadjuvant TCHP Chemotherapy
An observational study of HER2-positive Breast Cancer and Chemotherapy Effect, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer, Chemotherapy Effect, Circulating Tumor DNA
- What is being tested?
- LiquidSCAN(Trade Mark) / CancerSCAN(Trade Mark)
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2018to 31 Aug 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced HER2 positive breast cancer receiving neoadjuvant chemotherapy with docetaxel, carboplatin, trastuzumab and pertuzumab (TCHP) regimen
Who may be able to join
- HER2+ Breast cancer
- Stage IIA - IIIC
- Plan to receive neoadjuvant chemotherapy with docetaxel, carboplatin, herceptin, perjeta
- Sign to informed consent
Who cannot join
- Double primary cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- LiquidSCAN(Trade Mark) / CancerSCAN(Trade Mark)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiquidSCAN(Trade Mark) / CancerSCAN(Trade Mark)Diagnostic test
LiquidSCAN : detection of circulating DNA CancerSCAN : detection of somatic mutation using tumor tissue
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response
pCR of neoadjuvant(TCHP) chemotherapy with the patients with HER2 positive BC.
Measured: Pathologic Clinical response is performed after end of cycle 6 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Mar 2018
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeon Hee Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276337
- Sponsor's protocol ID
- 2018-01-054
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Characteristics of HER2 Positive Breast Cancer Receiving Neoadjuvant Chemotherapy With Docetaxel, Carboplatin, Trastuzumab and Pertuzumab (TCHP) Regimen
- ClinicalTrials.gov ID
- NCT04276337
- Acronym / sponsor ID
- 2018-01-054
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced HER2 positive breast cancer receiving neoadjuvant chemotherapy with docetaxel, carboplatin, trastuzumab and pertuzumab (TCHP) regimen
Key inclusion criteria (4 listed)
- HER2+ Breast cancer
- Stage IIA - IIIC
- Plan to receive neoadjuvant chemotherapy with docetaxel, carboplatin, herceptin, perjeta
- Sign to informed consent
Key exclusion criteria (1 listed)
- Double primary cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiquidSCAN(Trade Mark) / CancerSCAN(Trade Mark)LiquidSCAN : detection of circulating DNA CancerSCAN : detection of somatic mutation using tumor tissue | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer and Chemotherapy Effect, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (time frame: Pathologic Clinical response is performed after end of cycle 6 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.