TAM-01 / Mount Tam - LARVOL DELTA

Acolbifene vs tamoxifen for breast cancer prevention in premenopausal women at high risk for breast cancer. (ASCO 2025) - P2 | "Funded by National Cancer Institute Clinical Trial Registration Number: NCT05941520 Background: The TAM01 trial of low dose (5 mg) tamoxifen (LDTAM) vs placebo was associated with significant improvement in risk for breast cancer in postmenopausal women with a hazard ratio of 0.30 along with a favorable side effect profile. Target enrollment in this 4-site trial is 80 over 2.5 years. The protocol opened for accrual at the University of Kansas Medical Center in October 2024 and as of January 2025 is pending activation at the other sites."

Clinical • Breast Cancer • Oncology • Solid Tumor • AGR2

Predictive Effect of IGFBP-3 on Low-Dose Tamoxifen Efficacy in Noninvasive Breast Cancer in the Phase III Tam-01 Trial. (PubMed, Clin Cancer Res) - "Baseline IGF-I, estradiol, or SHBG levels were not predictive of babytam efficacy, whereas the IGF-I/IGFBP-3 ratio was borderline significant (Pinteraction = 0.067). High baseline levels of IGFBP-3 (≥3.44 µg/mL) predicted babytam efficacy and may help differentiate which women benefit most from this treatment."

Journal • P3 data • Breast Cancer • Oncology • Solid Tumor • IGF1 • IGFBP3

Insights adjusting for non-adherence in randomized clinical trials: a reanalysis of an adjuvant trial of tamoxifen duration in early breast cancer. (PubMed, Br J Cancer) - "This analysis emphasizes both the importance of adherence to hormonotherapy in hormone-receptor positive early BC and the usefulness of more complex statistical analyses."

Adherence • Clinical • Journal • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER

"In TAM-01, no statistically significant difference in DVT/PE between baby tam and placebo." (@drteplinsky)

Clinical

Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Recurrence in Breast Noninvasive Neoplasia: A 10-Year Follow-Up of TAM-01 Study. (PubMed, J Clin Oncol) - "Tamoxifen 5 mg once daily for 3 years significantly prevents recurrence from noninvasive breast cancer after 7 years from treatment cessation without long-term adverse events."

Journal • Breast Cancer • Oncology • Solid Tumor

Low-dose tamoxifen for breast cancer prevention in patients with ductal carcinoma in situ (DCIS) and atypical lesions: A real-world experience. (ASCO 2022) - "The recent Tam01 study found that low dose tamoxifen (5mg daily for 3 years) in patients with DCIS, ALH, and ADH resulted in an approximate 50% risk reduction in BC events compared to placebo with a slight increase in hot flashes but no increases in uterine cancer or venous thromboembolism within the tamoxifen group (PMID: 30973790). At our institution, in patients offered both low dose and standard dose tamoxifen, more than 75% started low dose tamoxifen. The low dose option was more frequently used for atypical lesions such as ADH, ALH and LCIS. In women at higher risk of invasive BC who may be reluctant to start standard dose tamoxifen or intolerant of it, low dose tamoxifen should be considered and offered."

Clinical • Real-world evidence • Breast Cancer • Cardiovascular • CNS Disorders • Insomnia • Oncology • Sleep Disorder • Solid Tumor • Uterine Cancer • Venous Thromboembolism

Trichoderma spp. on treatment of Handroanthus serratifolius seeds: effect on seedling germination and development. (PubMed, Heliyon) - "After 365 days, plants which received TAM01 pre-planting treatments were observed to have increased root and aerial part length, as well as root mass and overall dry mass. These results suggest that T. asperellum -TAM01 positively affects H. serratifolius development."

Journal