Breast cancer
Conditions
Interventions
Omitting breast surgery after preoperative chemotherapy
Sponsors
Mukai Hirofumi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year distant metastasis free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival Relaplse free survival Overall survival Local recurrence rate Adverse events Cosmetic maintenance rate | — |
Contacts
Public ContactMaruyama Yuri
CSPOR-BC
Outcome results
None listed