Low Dose Tamoxifen for Breast Cancer

(LoTam Trial)

Recruiting at 112 trial locations

Overseen By Jack Beranek

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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

My breast cancer is classified as low risk by the MammaPrint test.

My breast cancer recurrence risk score is 40 or less.

My breast cancer is estrogen receptor positive.

Treatment Details

Interventions

• Tamoxifen (Anti-estrogen)

Trial Overview The LoTam Trial is testing the effectiveness of low dose tamoxifen against usual hormonal therapies like anastrozole, letrozole, and exemestane in treating early stage breast cancer. The study aims to see if tamoxifen, which blocks estrogen in the breast, could be more effective than aromatase inhibitors that prevent formation of estradiol.

Participant Groups

Group I: Arm II (low dose tamoxifen) Experimental Treatment 6 Interventions

Patients receive low-dose tamoxifen PO QOD for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients may also undergo mammogram or MRI, DEXA, and blood sample collection on study.

Group II: Arm I (anastrozole, letrozole, exemestane, tamoxifen) Active Control 9 Interventions

Patients receive standard of care endocrine therapy per physician choice with either anastrozole PO, letrozole PO, exemestane PO or standard dose tamoxifen PO QD for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients may also undergo mammogram or MRI, DEXA, and blood sample collection on study.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+