OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
NCT ID: NCT05333328
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
418 participants
INTERVENTIONAL
2023-02-06
2033-01-31
Brief Summary
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In these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OFS with endocrine
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.
Ovarian 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.
Interventions
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Ovarian 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.
Eligibility Criteria
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Inclusion Criteria
* Premenopausal and age \<=50
* T1 or T2
* N1 including micrometastasis
* Genomic Low Risk by OncoFREE test® (1-20)
Exclusion Criteria
* ER-negative breast cancer
20 Years
50 Years
FEMALE
No
Sponsors
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Seoul National University
OTHER
Gangnam Severance Hospital
OTHER
Responsible Party
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Sung Gwe Ahn
Associated Professor
Principal Investigators
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Sung Gwe Ahn, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Gangnam Severance Hospital
Locations
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Gangnam Severance Hospital
Seoul, Korea, South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Hyeoung Gon Moon
Role: primary
Other Identifiers
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2021-1151-002
Identifier Type: -
Identifier Source: org_study_id
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