Clinical trial · Observational
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
NCT05433753CI-TRIAL-00075348recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Invasive disease-free survival (IDFS)
- timeFrame
- The duration from the date of surgery until the date of first documented the IDFS events, whichever comes first, up to 3 years.
- description
- ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer
Secondary outcomes (2)
- measure
- Overall survival (OS)
- timeFrame
- The duration from the date of surgery until the date of death from any cause, up to 3 years.
- description
- Death attributable to any cause
- measure
- Disease-free survival (DFS)
- timeFrame
- The duration from the date of surgery until the date of first documented the DFS events, whichever comes first, up to 3 years.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.