Assessing minimal residual disease in HER2-positive early breast cancer patients in Asia
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
Run by National Cancer Center, Japan · NCT05433753 · Data updated 2026-11-12
This study is trying to see if checking for tiny amounts of cancer DNA in the blood can help predict if HER2-positive early breast cancer patients in Asia are at risk of their cancer coming back after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | National Cancer Center, Japan Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chuo-ku, Tokyo) |
| Status | Recruiting |
| Started | May 24, 2022 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | March 25, 2024 |
| Trial ID | NCT05433753 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 20 years or older with a histological diagnosis of HER2-positive invasive breast carcinoma scheduled for neoadjuvant chemotherapy.
✕Probably not a fit
Patients with a history of other malignancies, bilateral synchronous breast cancer, or those who are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the relationship between the detection of minimal residual disease (MRD) and recurrence in HER2-positive early breast cancer patients across various Asian countries. Blood samples will be collected regularly to analyze circulating tumor DNA (ctDNA) in patients undergoing neoadjuvant chemotherapy followed by surgery. The study seeks to determine the timing and methods for ctDNA analysis to predict recurrence risk, potentially guiding treatment decisions and avoiding overtreatment in low-risk patients while intensifying treatment for high-risk individuals.
Why it matters
Potential benefit: If successful, this study could provide a reliable biomarker for predicting cancer recurrence, leading to more personalized treatment strategies for patients.
How similar studies have gone: While there is limited data on ctDNA analysis in this specific context, similar studies have shown promise in using MRD detection to guide treatment decisions in cancer care.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age of 20 years or older at the date of registration. 2. Histological diagnosis of HER2-positive invasive breast carcinoma. 3. Patients scheduled for neoadjuvant chemotherapy followed by surgery. 4. Clinical Stage IIA-IIIC. 5. Known hormone receptor status. 6. Signed informed consent. Exclusion Criteria: 1. 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. 2. Bilateral synchronous breast cancer. 3. History of breast cancer. 4. Pregnancy at registration.
Where it's running
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National Cancer Center Hospital, Japan
Chuo-ku, Tokyo, Japan Recruiting
Study contacts
- Principal investigator: Sho Shiino, MD, PhD — Department of Medical Oncology, National Cancer Cancer Hospital
- Study coordinator: Yuki Kojima, MD, PhD
- Email: yuukojim@ncc.go.jp
- Phone: 0335422511
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.