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

Yonsei University Health System (YUHS)

Status and phase: Enrolling; Phase 4

Conditions: Node-positive Breast Cancer; Breast Cancer; HER2-negative Breast Cancer; Estrogen Receptor Positive Tumor; Premenopausal Breast Cancer

Treatments: Drug: Ovarian function suppression with endocrine treatments

Study type: Interventional

Funder types: Other

Identifiers

NCT05333328

2021-1151-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 418 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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418 participants in 1 patient group

OFS with endocrine

Experimental group

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.

Treatment:

Drug: Ovarian function suppression with endocrine treatments