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

Primary Purpose

Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ovarian function suppression with endocrine treatments
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer, Node-positive Breast Cancer, Multigene assay, Ovarian-function suppression

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gangnam Severance HospitalRecruiting
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OFS with endocrine

Arm Description

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.

Outcomes

Primary Outcome Measures

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 Outcome Measures

Recurrence-free survival (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
Invasive disease-free survival (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

Full Information

First Posted
April 11, 2022
Last Updated
February 7, 2023
Sponsor
Gangnam Severance Hospital
Collaborators
Seoul National University
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1. Study Identification

Unique Protocol Identification Number
NCT05333328
Brief Title
OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
Acronym
INTERSTELLAR
Official Title
Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
Collaborators
Seoul National University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer, Node-positive Breast Cancer
Keywords
Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer, Node-positive Breast Cancer, Multigene assay, Ovarian-function suppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
De-escalating treatment as ovarian-function suppression with endocrine treatments alone in ER+HER2- premenopausal women with N1
Masking
None (Open Label)
Allocation
N/A
Enrollment
418 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OFS with endocrine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ovarian function suppression with endocrine treatments
Intervention Description
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 Outcome Measure Information:
Title
Distant recurrence-free survival
Description
The interval between the date of primary surgery and the date of last censored, or distant recurrence or death of any cause
Time Frame
5-years distant recurrence-free survival
Secondary Outcome Measure Information:
Title
Recurrence-free survival (RFS)
Description
The interval between the date of primary surgery and the date of last censored, or any type of recurrence or death of any cause
Time Frame
5-years RFS
Title
Invasive disease-free survival (iDFS)
Description
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
Time Frame
5-years iDFS

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Gwe Ahn, M.D.,Ph.D.
Phone
0220193370
Email
asg2004@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Gwe Ahn, M.D.,Ph.D.
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
06229
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Gwe Ahn, MD, PhD
Phone
0220193370
Email
asg2004@yuhs.ac
Email
asg2004@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Sung Gwe Ahn, MD.,PH.D.
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyeoung Gon Moon

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

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