Status:
RECRUITING
Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study
Lead Sponsor:
National Cancer Center, Japan
Conditions:
HER2-positive Breast Cancer
Eligibility:
All Genders
20+ years
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 re...
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 regular...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05433753
Start Date
May 24 2022
End Date
September 30 2027
Last Update
March 25 2024
Active Locations (1)
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1
National Cancer Center Hospital, Japan
Chuo-ku, Tokyo, Japan, 104-0045