Low Dose Tamoxifen for Breast Cancer
(LoTam Trial)
Trial Summary
What is the purpose of this trial?
This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to treat postmenopausal women with hormone-dependent breast cancer. Giving low dose tamoxifen may be more effective compared to usual hormone therapy in treating post-menopausal women with hormone-positive, HER2 negative early stage breast cancer.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any endocrine therapy for breast cancer prevention or osteoporosis, including tamoxifen or hormone replacement therapy, when you start the trial.
What data supports the effectiveness of the drug Tamoxifen for breast cancer?
Is low-dose tamoxifen safe for humans?
How is low-dose tamoxifen different from other breast cancer drugs?
Eligibility Criteria
This trial is for post-menopausal women with hormone-positive, HER2 negative early stage breast cancer. Participants must have a specific type of invasive breast cancer that's estrogen receptor positive and not spread to lymph nodes. Tumors should be small (≤3cm) and surgically removed with clear margins. Women who've had certain high-risk scores on cancer recurrence tests or evidence of lymph node involvement can't join.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either low-dose tamoxifen or standard-of-care endocrine therapy for up to 5 years
Follow-up
Participants are monitored for recurrence-free interval, adverse events, and overall survival
Treatment Details
Interventions
- Tamoxifen
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator