Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Node-positive Breast Cancer, Premenopausal Breast Cancer
Conditions
Keywords
Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer, Node-positive Breast Cancer, Multigene assay, Ovarian-function suppression
Brief summary
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.
Detailed description
* 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.
Interventions
DRUGOvarian function suppression with endocrine treatments
* 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.
Sponsors
Seoul National University
Gangnam Severance Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
De-escalating treatment as ovarian-function suppression with endocrine treatments alone in ER+HER2- premenopausal women with N1
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* ER+HER2- breast cancer * Premenopausal and age \<=50 * T1 or T2 * N1 including micrometastasis * Genomic Low Risk by OncoFREE test® (1-20)
Exclusion criteria
* Postmenopausal women * ER-negative breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distant recurrence-free survival | 5-years distant 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Invasive disease-free survival (iDFS) | 5-years 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 |
| Recurrence-free survival (RFS) | 5-years 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 |
Countries
South Korea
Contacts
Primary ContactSung Gwe Ahn, M.D.,Ph.D.
Outcome results
None listed