OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

Sponsor
Gangnam Severance Hospital
Study ID
NCT05333328
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Ovarian function suppression with endocrine treatments — DRUG
    * 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 Details

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.

Key Dates

First listed
Apr 18, 2022
Start date
Feb 6, 2023
Status verified
May 2025
Primary completion
Jan 31, 2031
Completion
Jan 31, 2033

Study Design

Enrollment
418 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Distant recurrence-free survival [ Time Frame: 5-years distant recurrence-free survival ]

Central Contacts

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