TAMOXIFEN CITRATE
TAMOXIFEN CITRATE is indicated for the treatment of Metastatic Breast Cancer; Breast Cancer; Ductal Carcinoma In Situ.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2003-02-20
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TAMOXIFEN CITRATE Approval History
What TAMOXIFEN CITRATE Treats
3 indicationsTAMOXIFEN CITRATE is approved for 3 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic Breast Cancer
- Breast Cancer
- Ductal Carcinoma In Situ
TAMOXIFEN CITRATE Boxed Warning
WARNING For Women With Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies , Reduction in Breast Cancer Incidence in High Risk Women ). Uterine malignancies...
WARNING For Women With Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies , Reduction in Breast Cancer Incidence in High Risk Women ). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for tamoxifen vs. 0.4 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for tamoxifen versus 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen citrate outweigh its risks in women already diagnosed with breast cancer. *Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS: Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma . **See Table 3 under CLINICAL PHARMACOLOGY, Clinical Studies .
TAMOXIFEN CITRATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 TAMOXIFEN CITRATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TAMOXIFEN CITRATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TAMOXIFEN CITRATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
119 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06195306 | NCI-2023-10830 NCI-2023-10830, UMICC 2024.076 | Ph 2 | recruiting | Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction |
| NCT05941520 | NCI-2023-05217 NCI-2023-05217, UMCC 2022.055 | Ph 2 | recruiting | Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer |
| NCT06184750 | NCI-2023-10628 NCI-2023-10628, NCI23-14-01 | Ph 2 | recruiting | Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial |
| NCT06979596 | 5684-015 2024-519563-18-00, U1111-1315-5430 | Ph 2 | recruiting | A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) |
| NCT06075953 | RECAST-DCIS | Ph 2 | recruiting | DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment |
| NCT06671912 LoTam | A012301 NCI-2024-06672 | Ph 3 | suspended | Testing Low Dose Tamoxifen for Invasive Breast Cancer, the (LoTam) Trial |
| NCT05774951 CAMBRIA-1 | D8531C00002 2022-501024-20-00 | Ph 3 | recruiting | A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy |
| 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 |
| NCT05306340 | ML43171 2022-000199-20, 2023-506821-12-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) |
| NCT05501704 | 22-225 | Ph 2 | recruiting | ETHAN - ET for Male BC |
| NCT06630325 results posted | STUDY00026643 NCI-2024-07664, STUDY00026643 | Ph 2 | terminated | A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer |
| NCT06434064 | I-3671523 NCI-2024-03909, I-3671523 | Ph 2 | recruiting | Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer |
| NCT06492616 ELEGANT | STML-ELA-0422 2024-515445-42-00 | Ph 3 | recruiting | A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence |
| NCT05768139 PIKALO-1 | 27691 2023-504807-94-00, 2023-000442-41 | Ph 1, Ph 2 | recruiting | First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors |
| NCT07535905 REVIVE | 25-5742 | Ph 2 | not yet recruiting | Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients |
| NCT06179303 | RG1122019 NCI-2022-06409, FHIRB0020029 | Ph 2 | recruiting | Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer |
| NCT06440967 | 2693-CL-1303 2024-510719-31-00 | Ph 3 | active not recruiting | A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy |
| NCT05514054 EMBER-4 | 18459 J2J-MC-JZLH, 2022-501007-28 | Ph 3 | active not recruiting | A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer |
| NCT05161195 | CLEE011A2412B 2024-514891-41-00 | Ph 4 | active not recruiting | Roll-over Study to Allow Continued Access to Ribociclib |
| NCT07499999 BabyTEARS | 25-550 | Ph 2 | not yet recruiting | Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer |
| NCT05659563 EMPRESS results posted | MEDOPP459 2022-002166-33, 2023-503565-36-00 | Ph 2 | completed | Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% |
| NCT00893061 MNEMOSYNE | MNEMOSYNE-0712 2008-003620-32 | Ph 3 | completed | Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer |
| NCT04059484 AMEERA-3 results posted | ACT16105 U1111-1217-2774, 2018-004593-98 | Ph 2 | terminated | Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer |
| NCT06348134 | IRB23-0502 | Ph 2 | recruiting | Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery |
| NCT04504331 results posted | IRB-53650 BRS0113, K08CA252457 | Ph 1 | terminated | Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer |
| NCT05101564 results posted | IRB-52869 NCI-2023-02578 | Ph 2 | completed | Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- 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 |
| NCT02747004 Next MONARCH 1 results posted | 16339 I3Y-MC-JPCG, 2016-000288-18 | Ph 2 | active not recruiting | A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer |
| NCT02057133 | 15252 I3Y-MC-JPBH | Ph 1 | active not recruiting | A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread |
| NCT04570956 | CA237607 NCI-2022-02973, 5R01CA237607-05 | Ph 2 | terminated | Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma In Situ, or Increased Breast Cancer Risk |
| NCT03879577 results posted | IRB18-1178 | Ph 2 | active not recruiting | Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer |
| NCT02668666 results posted | BTCRC BRE15-016 | Ph 2 | completed | Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer |
| NCT06001762 | 23-355 | Ph 2 | active not recruiting | TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer |
| NCT04906395 OVELIA | TOL2506A | Ph 3 | active not recruiting | Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer |
| NCT05645536 | TOL2506A-EXT | Ph 3 | enrolling by invitation | Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study |
| NCT05150652 | MCC-21-BRE-54 | Ph 2 | active not recruiting | Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage 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 |
| NCT05035836 | 2021-0358 NCI-2021-09420 | Ph 2 | recruiting | A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC) |
| 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 |
| NCT03280563 MORPHEUS HR+BC results posted | CO39611 2017-000335-14 | Ph 1, Ph 2 | completed | A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer |
| NCT05128773 AMEERA-6 results posted | EFC16133 U1111-1244-1767, BIG 20-01 | Ph 3 | terminated | Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity |
| NCT05512364 TREAT ctDNA | EORTC-2129-BCG | Ph 3 | recruiting | Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA) |
| NCT04300790 METALLICA | MEDOPP240 2019-003970-26 | Ph 2 | completed | Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients |
| NCT02476786 | 201611010 | Ph 2 | recruiting | Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score |
| NCT04765098 | IIT-0014 | Ph 2 | recruiting | Tamoxifen Versus Etoposide After First Recurrence in GBM Patients |
| NCT05952557 CAMBRIA-2 | D8535C00001 2023-504031-41-00 | Ph 3 | recruiting | An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) |
| 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 |
| NCT03554044 | 17753 NCI-2018-00652 | Ph 1 | completed | T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer |
| NCT05156892 TICTOC | TICTOC | Ph 1 | active not recruiting | Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer |
Showing 50 of 119 trials
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.
TAMOXIFEN CITRATE FDA Label Details
Indications & Usage
TAMOXIFEN CITRATE is indicated for the treatment of Metastatic Breast Cancer; Breast Cancer; Ductal Carcinoma In Situ.
WARNING For Women With Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment