Purpose of this Study
We are doing this study to compare the usual treatment with hormonal therapy medications to treatment with low-dose tamoxifen. We want to know which option has better outcomes for people with low-risk early-stage breast cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with unilateral invasive breast adenocarcinoma
- Have HER2 negative disease
- Are ER+ in at least 10% of cells
- Have no evidence of metastases (spread)
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- Group 1: If you are in this group, you will get the usual drug used to treat this type of cancer, either anastrozole, letrozole, exemestane, or tamoxifen 20 mg/day, decided by you and your physician. You will take one of these hormonal therapy drugs as a pill you take by mouth every day for a total of 5 years.
- Group 1: If you are in this group, you will get tamoxifen that is prescribed at a lower dose. You will take this hormonal therapy as a pill you take by mouth every other day for a total of 5 years.
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A012301: LoTam: A randomized, Phase III Ccinical trial of low-dose tamoxifen for selected patients with molecular low-risk early-stage Breast Cancer
Principal Investigator
Rani
Bansal
Protocol Number
PRO00117825
NCT ID
NCT06671912
Phase
III
Enrollment Status
Open to Enrollment