OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk

Breast Cancer Clinical Trial

— INTERSTELLAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333328
• Other study ID #: 2021-1151-002
• Status: Recruiting
• Phase: Phase 4
• Start date: February 6, 2023
• Est. completion date: January 2033

Study information

• Verified date: December 2022
• Source: Gangnam Severance Hospital
• Contact: Sung Gwe Ahn, M.D.,Ph.D.
• Phone: 0220193370
• Email: asg2004[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 418
• Est. completion date: January 2033
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Estrogen Receptor Positive Tumor
• HER2-negative Breast Cancer
• Node-positive Breast Cancer
• Premenopausal Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul	Korea
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Gangnam Severance Hospital	Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	5-years RFS
Secondary	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	5-years iDFS