OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk (INTERSTELLAR)

February 7, 2023 updated by: Sung Gwe Ahn, Gangnam Severance Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • 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.

Study Type

Interventional

Enrollment (Anticipated)

418

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
          • Hyeoung Gon Moon
    • Korea
      • Seoul, Korea, Korea, Republic of, 06229
        • Recruiting
        • Gangnam Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5-years distant recurrence-free survival

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5-years RFS
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
5-years iDFS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Collaborators

Seoul National University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 6, 2023

Primary Completion (ANTICIPATED)

January 1, 2028

Study Completion (ANTICIPATED)

January 1, 2033

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (ACTUAL)

April 18, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-1151-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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