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Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study

RECRUITINGSponsored by National Cancer Center, Japan
Actively Recruiting
SponsorNational Cancer Center, Japan
Started2022-05-24
Est. completion2027-09-30
Eligibility
Age20 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05433753

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

Age: 20 Years+Healthy volunteers accepted
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.

Conditions3

Breast CancerCancerHER2-positive Breast Cancer

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