Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study
Recruiting · NCT05433753 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
20 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- National Cancer Center Hospital, Japan - Chuo-ku, Tokyo, Japan