EA1242 (RxFINE-Low)

What is the Purpose of this Study?

This study compares standard treatment that includes chemotherapy, hormone therapy, and ribociclib with a treatment that uses only hormone therapy and ribociclib. Researchers want to learn if chemotherapy is needed for all patients with this type of cancer.

What is the Condition Being Studied?

People with breast cancer.

Who Can Participate in the Study?

Participants may be able to join if they are adults who are postmenopausal women or men with a certain type of hormone sensitive, HER2 negative breast cancer. They must have had breast cancer surgery within the past 16 weeks. People with certain forms of noninvasive breast cancer may also be eligible.

Age Group
Adults

What is Involved?

This study is comparing the usual treatment of chemotherapy followed by hormone therapy and ribociclib with treatment using hormone therapy and ribociclib alone in postmenopausal women and men. Researchers want to learn if patients can be treated successfully without chemotherapy.

Study Details

Full Title
EA1242: A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment For High Anatomic Stage ER-pos/HER2-neg Breast Cancer with RS<25 (RxFINE-Low)
Principal Investigator
Professor of Medicine
Protocol Number
IRB: PRO00120668
NCT: NCT07391774
Phase
Phase III
ClinicalTrials.gov
Status
OPEN TO ACCRUAL