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RecruitingPhase 4NCT05333328

OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

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

Sponsor

Gangnam Severance Hospital

Enrollment

418 participants

Start Date

Feb 6, 2023

Study Type

INTERVENTIONAL

Conditions

Breast CancerNode-positive Breast CancerHER2-negative Breast CancerEstrogen Receptor Positive TumorPremenopausal Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding ovarian function suppression (OFS) — stopping the ovaries from making estrogen — to standard hormone therapy provides an additional benefit for premenopausal women with early-stage, hormone-sensitive breast cancer that has spread to nearby lymph nodes but has a low genetic risk profile. **You may be eligible if...** - You are premenopausal and 50 years old or younger - You have hormone receptor-positive, HER2-negative breast cancer - Your tumor is T1 or T2 (early stage) - You have limited lymph node involvement (N1, including micrometastasis) - Your tumor has a low genomic risk score based on the OncoFREE test (score 1–20) **You may NOT be eligible if...** - You are postmenopausal - Your breast cancer is estrogen receptor-negative Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(2)

Gangnam Severance Hospital

Seoul, Korea, South Korea

Seoul National University Hospital

Seoul, South Korea

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NCT05333328

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