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OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

Study acronym: INTERSTELLAR
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Jan 2028 to Jan 2031v5
  2. Phase: Phase 2 to Phase 4
    • Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Jan 2023 to Feb 6, 2023
    v4
  3. Enrollment target: 343 to 418
    • Eligibility criteria expanded, about 2 words
    v3
  4. Secondary endpoints revised (2)
    • Study description revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05333328
Lead Sponsor Gangnam Severance Hospital
Collaborators: Seoul National University
Conditions
(from sponsor)		 Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer, Node-positive Breast Cancer
Related terms Breast Neoplasms
Enrollment 418 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov