| Clinical Trial Title |
LoTam: A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients with Molecular Low-Risk Early-Stage Breast Cancer |
| Trial Status |
Open to Enrollment |
| Start Date |
05/19/2025 |
| Location |
All Hospitals |
| Trial Type |
Cancer - Adult Oncology |
| Specific Condition |
Breast Cancer |
| Description |
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 |
Registration Eligibility Criteria
- Unilateral invasive adenocarcinoma of the breast that is histologically confirmed
- Invasive breast cancer is estrogen receptor positive in ≥10% of cells
- HER2 negative by current ASCO/CAP guidelines
- The patient must have a multigene assay with a low-risk score, including any of the following (if more than one genomic assay was obtained, both are required to be lowrisk):
- Oncotype DX Recurrence Score ≤ 25
- Mamma Print low risk
- Tumor size must be ≤3 cm by pathologic evaluation.
- Adequate surgical removal of all clinically evident disease in the breast with either breast conserving surgery or mastectomy. Negative margins on
final pathology are required. Additional excisions may be performed to obtain clear margins before registration.
- No clinical (cN1, cN2, cN3) or pathologic (pN1mi, pN1, pN2, or pN3) evidence of lymph node involvement on either needle biopsy or surgical lymph node assessment. Patients with pN0(i+) or pN0 (mol+) are eligible.
- Surgical axillary staging (sentinel lymph node biopsy ± axillary lymph node dissection) is completed according to physician discretion.
- For patients with negative preoperative axillary ultrasonography, clinicians may selectively choose to forego surgical axillary staging. Ipsilateral axillary ultrasound showing no lymph node involvement with no evidence of lymphadenopathy or suspicious thickening is required in this scenario.
- An interval of no more than 20 weeks between the date of surgery and the date of registration.
- Must have had a bilateral mammogram or MRI within 6 months prior to registration.
- Must be intending to take endocrine therapy for at least 5 years duration
- No prior treatment with endocrine therapy or chemotherapy for the currently diagnosed breast cancer prior to registration. (Short course endocrine therapy of ≤ 6 weeks duration is acceptable after core biopsy and before surgery, if genomic testing is assessed on the biopsy core and meets eligibility requirements for a low-risk score.)
- Postmenopausal status confirmed
Please contact Legacy Oncology Research for additional study inclusion/exclusion information. |
| IRB Number |
Central IRB |
| Notes |
Study Details | Testing Low Dose Tamoxifen for Invasive Breast Cancer, the (LoTam) Trial | ClinicalTrials.gov |
| Principal Investigator |
Mei Dong, MD |
| Contact Name |
Oncology Clinical Research |
| Contact Phone |
503-413-8199 |
| Contact Fax |
503-413-6920 |
| Contact E-Mail |
oncologyresearch@lhs.org |
