A012301 LoTam Molecular Low-risk Early-Stage Breast Cancer
What is the 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.
What is the Condition Being Studied?
Low-Risk Early-Stage Breast Cancer
Who Can Participate in the Study?
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)
For more information, contact the study team at nick.jeffries@duke.edu.
Age Group
Adults
What is Involved?
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.
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
Assistant Professor of Medicine
Protocol Number
IRB:
PRO00117825
NCT:
NCT06671912
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF