OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)

Conditions
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Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer, Node-positive Breast Cancer

Intervention / Treatment
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* Drug: Ovarian function suppression with endocrine treatments


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: De-escalating treatment as ovarian-function suppression with endocrine treatments alone in ER+HER2- premenopausal women with N1
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFS with endocrine<br>Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, the patients with a genomic low risk using the multigene-assay (OncoFREE®) will be included in this arm. | Drug: Ovarian function suppression with endocrine treatments<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5-years distant recurrence-free survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 5-years iDFS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer, Node-positive Breast Cancer, Multigene assay, Ovarian-function suppression