RecruitingNCT05433753
Asian Multicenter Prospective Study in HER2 Positive Early Breast Cancer for Detecting MRD by ctDNA;HARMONY Study
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
Sponsor
National Cancer Center, Japan
Enrollment
60 participants
Start Date
May 24, 2022
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 20 Years
Inclusion Criteria6
- 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 Criteria4
- 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05433753
Related Trials
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
NCT0104237942 locations
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
NCT0710238121 locations
Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
NCT048865314 locations
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
NCT074596737 locations
A Study of Surgery and Radiotherapy in People With Breast Cancer
NCT070530857 locations