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.
Who Can Participate?
Eligibility
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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
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
Alexandra
Thomas
Protocol Number
PRO00120668
NCT ID
NCT07391774
Phase
III
Enrollment Status
Open to Enrollment