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NCT Number: NCT05333328

OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Estrogen Receptor Positive Tumor HER2-negative Breast Cancer Neoplasms Neoplasms by Site Node-positive Breast Cancer Premenopausal Breast Cancer Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Gangnam Severance Hospital, Seoul, Korea, South Korea

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Distant recurrence-free survival

    Time frame: 5-years 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

Secondary outcomes

  1. Recurrence-free survival (RFS)

    Time frame: 5-years 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

  2. Invasive disease-free survival (iDFS)

    Time frame: 5-years 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sung Gwe Ahn, M.D.,Ph.D.

CONTACT

[email protected]

0220193370

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Collaborators

  • Seoul National University

Registry information

Official study title

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

Acronym: INTERSTELLAR

Important dates

Study start
2023
Primary completion
2031
Study completion
2033
First posted
Apr 18, 2022
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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