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
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF