SOLTAMOX (tamoxifen citrate)
SOLTAMOX is indicated for the treatment of Metastatic Breast Cancer; Breast Cancer; Ductal Carcinoma in Situ.
How SOLTAMOX Works
Tamoxifen is a selective estrogen receptor modulator (SERM) that acts as both an estrogen agonist and antagonist. It competitively binds to estrogen receptors (ER) in breast tissue, which inhibits estrogen receptor signaling-dependent growth. This competition results in decreased proliferation of ER-positive breast cancer cells. Tamoxifen also demonstrates antitumor activity by inhibiting the induction and promoting the regression of estrogen-dependent mammary carcinomas.
Details
- Status
- Prescription
- First Approved
- 2005-10-29
- Routes
- ORAL
- Dosage Forms
- SOLUTION
SOLTAMOX Approval History
What SOLTAMOX Treats
3 indicationsSOLTAMOX is approved for 3 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic Breast Cancer
- Breast Cancer
- Ductal Carcinoma in Situ
SOLTAMOX Boxed Warning
UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS Serious and life-threatening events from the use of SOLTAMOX include uterine malignancies, stroke, and pulmonary embolism [see Warnings and Precautions (5.1 , 5.2) ] . Fatal cases of each type of event have occurred. Incidence rates per 1000 women-years for these events were estimated from the National Surgical Adjuvant Breast and Bowel Project (NSABP) P-1 trial in women at high risk for breast cancer [see Clinical Studies (14.4) ] : Endometrial ade...
WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS Serious and life-threatening events from the use of SOLTAMOX include uterine malignancies, stroke, and pulmonary embolism [see Warnings and Precautions (5.1 , 5.2) ] . Fatal cases of each type of event have occurred. Incidence rates per 1000 women-years for these events were estimated from the National Surgical Adjuvant Breast and Bowel Project (NSABP) P-1 trial in women at high risk for breast cancer [see Clinical Studies (14.4) ] : Endometrial adenocarcinoma: 2.20 for tamoxifen vs. 0.71 for placebo Uterine sarcoma: 0.17 for tamoxifen vs. 0.04 for placebo Stroke: 1.43 for tamoxifen vs. 1.00 for placebo. Pulmonary embolism: 0.75 for tamoxifen versus 0.25 for placebo. Discuss the potential benefits of tamoxifen versus the potential risks of these serious events with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) considering tamoxifen to reduce the risk of developing breast cancer [see Warnings and Precautions (5) ]. For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks. WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS See full prescribing information for complete boxed warning . Serious, life-threatening, and fatal events from use of tamoxifen include uterine malignancies, stroke, and pulmonary embolism. ( 5.1 , 5.2 ) Discuss risks and benefits of tamoxifen with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) when considering tamoxifen use to reduce the risk of developing breast cancer. ( 5.1 , 5.2 ) For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks. ( 5.1 , 5.2 )
SOLTAMOX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SOLTAMOX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SOLTAMOX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SOLTAMOX
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01272037 results posted | NCI-2011-02623 NCI-2011-02623, S12-03603 | Ph 3 | active not recruiting | Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer |
| NCT02311933 results posted | NCI-2014-02409 NCI-2014-02409, A011203 | Ph 2 | active not recruiting | Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer |
| NCT00893061 MNEMOSYNE | MNEMOSYNE-0712 2008-003620-32 | Ph 3 | completed | Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer |
| NCT01674140 e3 results posted | S1207 S1207, U10CA032102 | Ph 3 | active not recruiting | S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer |
| NCT01196936 LDTam results posted | 08218 R01CA140245-01, NCI-2010-01976 | Ph 2 | active not recruiting | Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors |
| NCT02101788 results posted | NCI-2014-00629 NCI-2014-00629, GOG-0281 | Ph 2, Ph 3 | completed | Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer |
| NCT00601900 results posted | NCI-2009-00477 NCI-2009-00477, CALGB-40503 | Ph 3 | completed | Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer |
| NCT00949598 | CDR0000638373 | Ph 3 | completed | Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer |
| NCT02993159 results posted | NCI 2015-06-04 P30CA060553, NCI-2016-01911 | Ph 2 | completed | Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast |
| NCT04129216 results posted | IRB00130428 | Ph 2 | completed | The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer |
| NCT03917082 LALEAST | LA LEAST | Ph 2 | active not recruiting | Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer |
| NCT02269670 results posted | IRB00071229 NCI-2014-02092, WINSHIP2563-13 | Ph 2 | terminated | Phase II Study of Everolimus Beyond Progression |
| NCT02197897 BCTamoxifen results posted | H-25233 K23CA160664 | Ph 2 | completed | Evaluation the Treatment of Tamoxifen of Low/Intermediate Risk Bladder Tumors |
| NCT00729586 results posted | NCI-2009-01085 NCI-2009-01085, GOG-0248 | Ph 2 | completed | Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer |
| NCT03238703 | 9764 NCI-2017-00724, 9764 | Ph 4 | withdrawn | Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer |
| NCT00764322 NRR results posted | LCCC 0801 P30CA016086, 08-0483 | Ph 2 | completed | Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen |
| NCT00952731 results posted | NWU07-9-02 NCI-2013-00452, NCI 07-9-02 | Ph 2 | completed | 4-Hydroxytamoxifen or Tamoxifen Citrate in Treating Women With Newly Diagnosed Ductal Breast Carcinoma in Situ |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SOLTAMOX FDA Label Details
Indications & Usage
FDA Label (PDF)SOLTAMOX is indicated for the treatment of Metastatic Breast Cancer; Breast Cancer; Ductal Carcinoma in Situ.
WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS Serious and life-threatening events from the use of SOLTAMOX include uterine malignancies, stroke, and pulmonary embolism [see Warnings and Precautions (5.1 , 5.2) ] . Fatal cases of each type of event have occurred. Incidence rates per 1000 wo...
Track SOLTAMOX with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.