NCT05433753 Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study
| NCT ID | NCT05433753 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Center, Japan |
| Condition | HER2-positive Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-05-24 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-05-24 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Sho Shiino, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Medical Oncology, National Cancer Cancer Hospital
Frequently Asked Questions
Who can join the NCT05433753 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying HER2-positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05433753 currently recruiting?
Yes, NCT05433753 is actively recruiting participants. Contact the research team at yuukojim@ncc.go.jp for enrollment information.
Where is the NCT05433753 trial being conducted?
This trial is being conducted at Chuo-ku, Japan.
Who is sponsoring the NCT05433753 clinical trial?
NCT05433753 is sponsored by National Cancer Center, Japan. The principal investigator is Sho Shiino, MD, PhD at Department of Medical Oncology, National Cancer Cancer Hospital. The trial plans to enroll 60 participants.
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