HER2-positive Breast CancerNCT05433753
Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study
An observational study of HER2-positive Breast Cancer, run by National Cancer Center, Japan at 1 site in Japan.
Trial summary
This study will assess minimal residual disease (MRD) in HER2-positive early breast cancer patients in Asian countries. The purpose is to evaluate the relation between the detection rate of MRD and recurrence. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- 24 May 2022to 30 Sep 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HER2-positive early breast cancer patients who have scheduled for neoadjuvant chemotherapy followed by surgery.
Who may be able to join
- Age of 20 years or older at the date of registration.
- Histological diagnosis of HER2-positive invasive breast carcinoma.
- Patients scheduled for neoadjuvant chemotherapy followed by surgery.
- Clinical Stage IIA-IIIC.
- Known hormone receptor status.
- Signed informed consent.
Who cannot join
- Any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the esophagus, stomach, colon, or cervix.
- Bilateral synchronous breast cancer.
- History of breast cancer.
- Pregnancy at registration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
National Cancer Center Hospital, Japan
Chuo-ku, Tokyo, 104-0045
Shiino Sho, MD,PhD
About this study
Official title: Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting Minimal Residual Disease by Circulating Tumor DNA Analysis With Neoadjuvant Chemotherapy; HARMONY Study
This study will assess minimal residual disease (MRD) in HER2-positive early breast cancer patients in Asian countries. The purpose is to evaluate the relation between the detection rate of MRD and recurrence.
Read the detailed description
This study will evaluate the relation between the detection rate of minimal residual disease(MRD) and recurrence in HER2-positive early breast cancer patients in Asian countries. Blood will be regularly collected to check the presence of ctDNA in HER2-positive breast cancer patients who have scheduled for neoadjuvant chemotherapy followed by surgery. Prognostic data is also collected on the same patients.
MRD is a small number of cancer cells left in the body during or after treatment. These cells have the potential to cause recurrence in cancer patients. MRD detection can help identify patients at increased risk of disease recurrence and guide treatment decisions. However, limited data are available on when ctDNA analysis should be done in the course of treatment, and what is the appropriate analysis method. This study will contribute to determining whether MRD detection using ctDNA is useful to predict the recurrence of HER2-positive early breast cancer patients. If this can be proven, it is expected that detection of MRD can use as a biomarker to assist in the de-/escalation of treatment strategies, therefore allowing to avoid overtreatment in patients at low risk, and to add more intensive treatment in patients at high risk. Moreover, studying with Asian countries, the results will become the basic data for approval of liquid biopsy.
- Conditions
- HER2-positive Breast Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive disease-free survival (IDFS)
ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer
Measured: The duration from the date of surgery until the date of first documented the IDFS events, whichever comes first, up to 3 years.
Secondary outcomes (2)
Overall survival (OS)
Death attributable to any cause
Measured: The duration from the date of surgery until the date of death from any cause, up to 3 years.
Disease-free survival (DFS)
IDFS events, ipsilateral or contralateral DCIS, second primary non-breast invasive cancer
Measured: The duration from the date of surgery until the date of first documented the DFS events, whichever comes first, up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start24 May 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Japan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sho Shiino, MD, PhD, Principal investigator, Department of Medical Oncology, National Cancer Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433753
- Sponsor's protocol ID
- NCCH2113
- Status last verified
- Mar 2024
- First submitted
- 7 Jun 2022
- Last updated
- 25 Mar 2024
- 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 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting Minimal Residual Disease by Circulating Tumor DNA Analysis With Neoadjuvant Chemotherapy; HARMONY Study
- ClinicalTrials.gov ID
- NCT05433753
- Acronym / sponsor ID
- NCCH2113
- Conditions
- HER2-positive Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Center, JapanOther government
- Study start
- 24 May 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 27 Jun 2022 (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.
This study will assess minimal residual disease (MRD) in HER2-positive early breast cancer patients in Asian countries. The purpose is to evaluate the relation between the detection rate of MRD and recurrence.
Detailed description
This study will evaluate the relation between the detection rate of minimal residual disease(MRD) and recurrence in HER2-positive early breast cancer patients in Asian countries. Blood will be regularly collected to check the presence of ctDNA in HER2-positive breast cancer patients who have scheduled for neoadjuvant chemotherapy followed by surgery. Prognostic data is also collected on the same patients.
MRD is a small number of cancer cells left in the body during or after treatment. These cells have the potential to cause recurrence in cancer patients. MRD detection can help identify patients at increased risk of disease recurrence and guide treatment decisions. However, limited data are available on when ctDNA analysis should be done in the course of treatment, and what is the appropriate analysis method. This study will contribute to determining whether MRD detection using ctDNA is useful to predict the recurrence of HER2-positive early breast cancer patients. If this can be proven, it is expected that detection of MRD can use as a biomarker to assist in the de-/escalation of treatment strategies, therefore allowing to avoid overtreatment in patients at low risk, and to add more intensive treatment in patients at high risk. Moreover, studying with Asian countries, the results will become the basic data for approval of liquid biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2-positive early breast cancer patients who have scheduled for neoadjuvant chemotherapy followed by surgery.
Key inclusion criteria (6 listed)
- Age of 20 years or older at the date of registration.
- Histological diagnosis of HER2-positive invasive breast carcinoma.
- Patients scheduled for neoadjuvant chemotherapy followed by surgery.
- Clinical Stage IIA-IIIC.
- Known hormone receptor status.
Key exclusion criteria (4 listed)
- Any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the esophagus, stomach, colon, or cervix.
- Bilateral synchronous breast cancer.
- History of breast cancer.
- Pregnancy at registration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Invasive disease-free survival (IDFS)
Time frame: The duration from the date of surgery until the date of first documented the IDFS events, whichever comes first, up to 3 years.
ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer
2 secondary outcomes
Overall survival (OS)
Time frame: The duration from the date of surgery until the date of death from any cause, up to 3 years.
Disease-free survival (DFS)
Time frame: The duration from the date of surgery until the date of first documented the DFS events, whichever comes first, up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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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.
Sho Shiino, MD, PhD principal investigator
Department of Medical Oncology, National Cancer Cancer Hospital
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, run by National Cancer Center, Japan at 1 site in Japan.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Mar 2024. 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 Japan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuki Kojima, MD, PhD (0335422511, yuukojim@ncc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive disease-free survival (IDFS) (time frame: The duration from the date of surgery until the date of first documented the IDFS events, whichever comes first, up to 3 years.). 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 25 Mar 2024.