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In HER2-positive ER-negative breast cancer with gene HSD17B4 hyperMethylation Prospective study Evaluating the usefulness of non-Surgical therapy

HERMES study

Mukai Hirofumi

National Cancer Center Hospital East

6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan

hrmukai@east.ncc.go.jp

Yuri Maruyama

CSPOR-BC

178-4-4-502 Wakashiba, Kashiwa-shi Chiba, Japan

+81-4-7135-5559

office-bc@cspor-bc.or.jp

Recruiting

June. 11, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

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

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

Female

Breast cancer

Omitting breast surgery after preoperative chemotherapy

Breast Neoplasms

3-year distant metastasis free survival

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

+81-72-804-0101

No

none