Assessing minimal residual disease in HER2-positive early breast cancer patients in Asia
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 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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Cancer Center, Japan Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chuo-ku, Tokyo) |
| Trial ID | NCT05433753 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chuo-ku, Tokyo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.