Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®). In these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.
* Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®). * In these, ovarian function suppression (OFS) with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years. * Either goserelin acetate or leuprorelin Acetate is allowed. * These patients are able to choose bilateral salpingo-oophorectomy instead of OFS. * Chemotherapy is omitted in these patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
418
* Ovarian function suppression (OFS) with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years. * Either goserelin acetate or leuprorelin Acetate is allowed. * These patients are able to choose bilateral salpingo-oophorectomy instead of OFS. * Chemotherapy is omitted in these patients.
Gangnam Severance Hospital
Seoul, Korea, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
NOT_YET_RECRUITINGDistant recurrence-free survival
The interval between the date of primary surgery and the date of last censored, or distant recurrence or death of any cause
Time frame: 5-years distant recurrence-free survival
Recurrence-free survival (RFS)
The interval between the date of primary surgery and the date of last censored, or any type of recurrence or death of any cause
Time frame: 5-years RFS
Invasive disease-free survival (iDFS)
The interval between the date of primary surgery and the date of last censored, or any type of invasive disease except thyroid cancer or death of any cause
Time frame: 5-years iDFS
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.