JRCT ID: jRCT2052240059
Registered date:11/06/2024
HERMES study
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Breast cancer |
Date of first enrollment | 18/09/2024 |
Target sample size | 250 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Omitting breast surgery after preoperative chemotherapy |
Outcome(s)
Primary Outcome | 3-year distant metastasis free survival |
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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 |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | Japan Agency for Medical Research and Development |
Secondary ID(s) |
Contact
Public contact | |
Name | Maruyama Yuri |
Address | 178-4-4-502 Wakashiba, Kashiwa-shi Chiba, Japan Chiba Japan 277-0871 |
Telephone | +81-4-7135-5559 |
office-bc@cspor-bc.or.jp | |
Affiliation | CSPOR-BC |
Scientific contact | |
Name | Hirofumi Mukai |
Address | 6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan Chiba Japan 277-8577 |
Telephone | +81-4-7133-1111 |
hrmukai@east.ncc.go.jp | |
Affiliation | National Cancer Center Hospital East |