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Low-dose tamoxifen
Low-dose tamoxifen acts as a selective estrogen receptor modulator (SERM) that blocks estrogen signaling in breast tissue while potentially having immunomodulatory effects at reduced doses.
Low-dose tamoxifen acts as a selective estrogen receptor modulator (SERM) that blocks estrogen signaling in breast tissue while potentially having immunomodulatory effects at reduced doses. Used for Hormone receptor-positive breast cancer (investigational low-dose formulation), Potential immunomodulatory applications (Phase 3 investigational).
At a glance
| Generic name | Low-dose tamoxifen |
|---|---|
| Also known as | LDT |
| Sponsor | National Taiwan University Hospital |
| Drug class | Selective estrogen receptor modulator (SERM) |
| Target | Estrogen receptor alpha (ERα) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Tamoxifen is a nonsteroidal antiestrogen that competitively binds to estrogen receptors, preventing estrogen-mediated proliferation in hormone-responsive breast cancer cells. At low doses, it may also exert immunomodulatory effects that enhance immune function, potentially useful in conditions beyond traditional hormone-responsive breast cancer.
Approved indications
- Hormone receptor-positive breast cancer (investigational low-dose formulation)
- Potential immunomodulatory applications (Phase 3 investigational)
Common side effects
- Hot flashes
- Vaginal discharge or bleeding
- Thromboembolic events
- Endometrial hyperplasia or cancer
- Nausea
Key clinical trials
- Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer (PHASE2)
- Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction (PHASE2)
- DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment (PHASE2)
- Long-term Follow-up of the TAM-01 Study and Pooled Analysis of Low-dose Tamoxifen Studies in Non-invasive or Microinvasive Breast Neoplasms
- Testing Low Dose Tamoxifen for Invasive Breast Cancer, the (LoTam) Trial (PHASE3)
- Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation (EARLY_PHASE1)
- Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors (PHASE2)
- Low Dose Exemestane vs Low Dose Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer. (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Low-dose tamoxifen CI brief — competitive landscape report
- Low-dose tamoxifen updates RSS · CI watch RSS
- National Taiwan University Hospital portfolio CI