HERMES study

JRCT ID: jRCT2052240059

Registered date:11/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 11/06/2024
• Target sample size: 250
• Study type: Interventional
• Intervention(s): Omitting breast surgery after preoperative chemotherapy

Outcome(s)

• Primary Outcome: 3-year distant metastasis free survival

Secondary Outcome

Disease free survival
Relaplse free survival
Overall survival
Local recurrence rate
Adverse events
Cosmetic maintenance rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Histologically confirmed invasive breast cancer, excluding invasive breast cancer with a predominant non-invasive component
2. Clinical T3 or lower on physical examination and imaging studies within 56 days prior to enrollment
3. Clinical stage N1 or lower on physical examination and imaging studies within 56 days prior to enrollment. Cytological or histological confirmation is not mandatory.
4. Non-metastatic operable breast cancer
5. HER2 positive breast cancer
6. Estrogen receptor negative
7. Women aged 20 years or older on the date of enrollment
8. Eastern Cooperative Oncology Group performance status of 0 to 1
9. No previous treatment with chemotherapy, endocrine therapy, anti-HER2 therapy and radiotherapy to the breast or chest
10. No previous history of non-invasive or invasive breast cancer
11. Left ventricular ejection fraction by echocardiogram or multigated acquisition scan of 55% and higher within 56 days prior to enrollment
12. Preserved organ functions within 28 days prior to enrollment
13. Signed written informed consent

Exclude criteria

1. History of other malignancy within the last 5 years
2. History of congestive heart failure, myocardial infarction. Concurrent arrhythmia or heart valvular disease requiring treatment
3. Current uncontrolled infections
4. Current pregnancy and/or lactation, possible pregnancy and within 28 days postpartum
5. Current uncontrolled diabetes mellitus
6. Current scleroderma and systemic lupus erythematosus
7. Current treatment with systemic steroids or immune suppressive agents
8. Unsuitable mental status for participation
9. Complications of interstitial pneumonia, pulmonary fibrosis or severe emphysema

Related Information

• Primary Sponsor: Mukai Hirofumi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development