Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Krishnamurthy, Jairam
Contact Information:
Anita Rogic
arogic@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05879926?term=NCT05879926&rank=1#participation-criteria
Summary
1.1 Primary Objective
To determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
1.2 Secondary Objectives
1.2.1 To determine whether ACT added to OFS plus ET is superior to OFS plus ET in improving invasive disease-free survival (IDFS) among premenopausal, EBC patients with ER-positive, HER2-negative tumors and 21-gene RS between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
1.2.2 To determine whether ACT added to OFS plus ET is superior to OFS plus ET in improving overall survival (OS) among premenopausal, EBC patients with ER-positive, HER2-negative tumors and 21-gene RS between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
1.2.3 To determine whether ACT added to OFS plus ET is superior to OFS plus ET in improving distant recurrence-free interval (DRFI) among premenopausal, EBC patients with ER-positive, HER2-negative tumors and 21-gene RS between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
1.2.4 To determine whether ACT added to OFS plus ET is superior to OFS plus ET in improving breast cancer-free interval (BCFI) among premenopausal, EBC patients with ER-positive, HER2-negative tumors and 21-gene RS between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
1.2.5 To determine whether patients who receive ACT added to OFS plus ET will have more severe menopausal symptoms, measured by the FACT ESS-19 score, compared to those who do not receive ACT.
1.2.6 To determine whether patients who receive ACT added to OFS plus ET will have increased pain during aromatase inhibitor (AI) therapy compared to patients who do not receive ACT.
1.3 Exploratory Objectives
1.3.1 To determine if there are differences in adherence to long-term OFS plus ET by treatment arm assignment.
1.3.2 To determine if there are differences in the degree of ovarian suppression between treatment arms.
1.3.3 To determine if ACT added to OFS plus ET increases the long-term toxicities of OFS plus ET in premenopausal women with EBC.
1.3.4 To determine whether patients who receive ACT added to OFS plus ET will have similar selected QOL outcomes during OFS plus ET compared to patients who do not receive ACT.
1.3.5 To assess if survival outcomes differ by race/ethnicity.
1.3.6 To determine if body mass index (BMI) contributes to outcome in this study population.