NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2052240059

Registered date:11/06/2024

HERMES study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment18/09/2024
Target sample size250
Countries of recruitment
Study typeInterventional
Intervention(s)Omitting breast surgery after preoperative chemotherapy

Outcome(s)

Primary Outcome3-year distant metastasis free survival
Secondary OutcomeDisease free survival Relaplse free survival Overall survival Local recurrence rate Adverse events Cosmetic maintenance rate

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderFemale
Include criteria1. 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 criteria1. 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

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
E-mail 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
E-mail hrmukai@east.ncc.go.jp
Affiliation National Cancer Center Hospital East