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

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05333328

Collaborator

Seoul National University (Other)

343

Enrollment

Location

Arm

120

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Estrogen Receptor Positive Tumor HER2-negative Breast Cancer Premenopausal Breast Cancer Node-positive Breast Cancer	Drug: Ovarian function suppression with endocrine treatments	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

343 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

De-escalating treatment as ovarian-function suppression with endocrine treatments alone in ER+HER2- premenopausal women with N1De-escalating treatment as ovarian-function suppression with endocrine treatments alone in ER+HER2- premenopausal women with N1

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Study)

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2028

Anticipated Study Completion Date :

Jan 1, 2033

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Distant recurrence-free survival [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 Outcome Measures

Recurrence-free survival (RFS) [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
Invasive disease-free survival (iDFS) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

ER+HER2- breast cancer
Premenopausal and age <=50
T1-3/N1
N1 including micrometastasis
Genomic Low Risk by OncoFREE test® (1-20)

Exclusion Criteria:

Postmenopausal women
ER-negative breast cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severance Hospital	Seoul	Korea	Korea, Republic of	06229

Sponsors and Collaborators

Gangnam Severance Hospital
Seoul National University

Investigators

Principal Investigator: Sung Gwe Ahn, M.D.,Ph.D., Gangnam Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sung Gwe Ahn, Associated Professor, Gangnam Severance Hospital

ClinicalTrials.gov Identifier:

NCT05333328

Other Study ID Numbers:

2021-1151-002

First Posted:

Apr 18, 2022

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Sung Gwe Ahn, Associated Professor, Gangnam Severance Hospital

Breast Cancer

Estrogen Receptor Positive Tumor

HER2-negative Breast Cancer

Premenopausal Breast Cancer

Node-positive Breast Cancer

Multigene assay

Ovarian-function suppression

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Apr 25, 2022