Nolvadex

(Tamoxifen)

ApprovedSmall molecule

Tamoxifen is used to treat breast cancer in women and men, and to reduce the risk of breast cancer in high-risk women. It works by blocking estrogen from helping cancer cells grow.[2] Nolvadex is currently approved and in use across 38 indications[4].[1]

Nolvadex is one of 581 small molecule programs targeting Gynecomastia. It is currently in Approved.

Indications

219

Total Trials

Active Trials

580

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

GynecomastiaApproved

Fallopian Tube CancerApproved

Peritoneum CancerApproved

Female Breast CarcinomaApproved

Pancreatic NeoplasmApproved

Chronic Hepatitis C Virus InfectionApproved

Breast NeoplasmApproved

Diffuse Large B-Cell LymphomaApproved

Barrett's EsophagusApproved

InfertilityApproved

GynecomastiaApproved

Approved

Fallopian Tube CancerApproved

Approved

Peritoneum CancerApproved

Approved

Female Breast CarcinomaApproved

Approved

Pancreatic NeoplasmApproved

Approved

Chronic Hepatitis C Virus InfectionApproved

Approved

Breast NeoplasmApproved

Approved

Diffuse Large B-Cell LymphomaApproved

Approved

Barrett's EsophagusApproved

Approved

InfertilityApproved

Approved

Showing 10 of 38 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Nolvadex

Lexiscan

1 3

Voltaren

Novartis

Preclinical

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Zolymbus

AbbVie

Preclinical

1 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Spravato

WWim Janssens

Preclinical

2 9

Duragesic-100

CCephalon

Preclinical

2 10

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Breast Cancer

NCT03879577

Q4 2026

Phase 3Active, not recruiting

Breast Cancer

NCT05306340

Phase 2Active, not recruiting

Breast Cancer

NCT03161353

Phase 2Active, not recruiting

Breast Cancer

NCT02747004

Phase 1Active, not recruiting

Breast Cancer

NCT02057133

Q1 2027

Phase 1Active, not recruiting

Ovarian Cancer

NCT05156892

Clinical

Trials by Indication[1]

Breast Cancer102 trials

Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer

Unknown status·PPeking Union Medical College Hospital·Phase 3·NCT02097459·600 enrolled

A Study to Evaluate the Effect of Letrozole and Tamoxifen on Bone and Lipids in Postmenopausal Women With Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00171704·263 enrolled

Effect of Metformin on Endometrial Thickness in Postmenopausal Breast Cancer Patients Receiving Tamoxifen

Completed·UUruk University·N/A·NCT07145827·60 enrolled

Show 99 more trials

Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394)

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00590785·60 enrolled

Trial of ZD1839 (Iressa) and Tamoxifen in Breast Cancer Patients

Terminated·BBaylor Breast Care Center·Phase 2·NCT00206492·3 enrolled

Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Completed·IInternational Breast Cancer Research Foundation·Phase 3·NCT00201851·740 enrolled

TAK-228 Plus Tamoxifen in Patients With ER-Positive, HER2-negative Breast Cancer

Completed·TThe Methodist Hospital Research Institute·Phase 2·NCT02988986·28 enrolled

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT02747004·234 enrolled

Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country

Completed·VVanderbilt University·Phase 2·NCT02806544·35 enrolled

Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer

Completed·UUniversity Hospital, Essen·Phase 2·NCT02404844·48 enrolled

Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer

Recruiting·RRoswell Park Cancer Institute·Phase 2·NCT06434064·30 enrolled

T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

Completed·UUniversity of California, San Francisco·Phase 1·NCT03554044·20 enrolled

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

Not yet recruiting·RRegion Örebro County·Phase 3·NCT06223698·3,832 enrolled

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

Recruiting·UUniversity of Washington·Phase 2·NCT06179303·60 enrolled

A Study to Evaluate Exemestane Tablets Combined With Ovarian Function Suppression/Ablation in Treatment of Premenopausal Breast Cancer Patients With CYP2D6*10 Mutations （STEP）

Unknown status·—·Phase 3·NCT03137368·300 enrolled

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 3·NCT00066690·3,066 enrolled

Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients

Unknown status·TTata Memorial Hospital·Phase 3·NCT00896155·260 enrolled

Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer

Suspended·TThe Netherlands Cancer Institute·Phase 2·NCT00738777·250 enrolled

Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+

Completed·IInstitut Cancerologie de l'Ouest·Phase 2·NCT01220076·140 enrolled

Neoadjuvant Treatment of Breast Cancer

Not yet recruiting·NNational Institute of Oncology, Hungary··NCT05131893·300 enrolled

Tamoxifen +/- GnRH Analogue vs Aromatase Inhibitor + GnRH Analogue in Male Breast Cancer Patients

Completed·GGBG Forschungs GmbH·Phase 3·NCT01638247·56 enrolled

Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00433589·6,600 enrolled

Evaluation of the Efficacy of Estramustine in Patient With Breast Cancer Progression After Treatment With Aromatase Inhibitor.

Completed·IInstitut de Cancérologie de Lorraine·Phase 2·NCT02866955·100 enrolled

Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02344940·104 enrolled

ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00286117·448 enrolled

Study of Cytochrome P450 Polymorphisms (CYP2D6, CYP3A4/5 and CYP2C19) in Breast Cancer Patients

Completed·YYonsei University··NCT01169792

Study of Tamoxifen Dose Escalation in Breast Cancer Patients With CYP2D6 Polymorphisms

Completed·WWestern Sydney Local Health District·N/A·NCT01075802·121 enrolled

Zoladex Plus Tamoxifen in Breast Cancer

Completed·ZZhejiang Cancer Hospital·N/A·NCT00827307·100 enrolled

Dose-determining and Dose-confirmatory Study to Investigate the Optimal Dose of Tamoxifen in Breast Cancer Patients According to Genotype Status of TCF20 rs932376

Unknown status·NNational Cancer Centre, Singapore·Phase 1·NCT04961632·75 enrolled

Comparative Evaluation of Efficacy and Safety of Toremifene, Tamoxifen, and Aromatase Inhibitor Plus Ovarian Function Suppression in Hormone Receptor-Positive Early Breast Cancer Among Non-Low-Risk Premenopausal Women: A Real-World Study

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University··NCT05801705·700 enrolled

Pembrolizumab and Tamoxifen With or Without Vorinostat for the Treatment of Estrogen Receptor Positive Breast Cancer

Terminated·UUniversity of California, San Francisco·Phase 2·NCT04190056·1 enrolled

A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00241449·51 enrolled

A Study for Safety and Effectiveness of IMC-A12 by Itself or Combined With Antiestrogens to Treat Breast Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00728949·93 enrolled

Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

Completed·—·Phase 2·NCT02668666·49 enrolled

Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT02291913·48 enrolled

Breast Cancer & Antiestrogenic Therapy & Brain

Not yet recruiting·IInternational Research Training Group 2804··NCT06346457·180 enrolled

The EMPOwER Study Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy Response in Hormone Receptor Positive Breast Cancers

Unknown status·OOttawa Hospital Research Institute·Phase 2·NCT03211572·82 enrolled

Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer

Terminated·JJennifer Lee Caswell-Jin·Phase 1·NCT04504331·4 enrolled

Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer

Withdrawn·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00053339

Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00605267·197 enrolled

ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00291759·3,858 enrolled

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05514054·8,000 enrolled

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

Terminated· Sanofi logo

Sanofi·Phase 3·NCT05128773·3 enrolled

Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer

Completed·JJennifer Lee Caswell-Jin·Phase 2·NCT05101564·19 enrolled

CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population

Unknown status·NNalagenetics Pte Ltd·N/A·NCT05501158·150 enrolled

Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 1·NCT02936206·2 enrolled

A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT02333370·88 enrolled

Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not

Completed·IInstitut Claudius Regaud·Phase 4·NCT01553903·29 enrolled

Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)

Recruiting·FFudan University·Phase 3·NCT05891093·766 enrolled

Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

Completed·EECOG-ACRIN Cancer Research Group·Phase 2·NCT01124695·124 enrolled

A Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors

Terminated·CCentre Francois Baclesse·Phase 2·NCT02322853·8 enrolled

Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer

Unknown status·ZZhiyong Yu·Phase 2/3·NCT03373708·200 enrolled

Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients

Completed·PPalleos Healthcare GmbH·Phase 2·NCT03272477·257 enrolled

TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT02586675·7 enrolled

Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer

Completed·IInternational Breast Cancer Research Foundation·Phase 3·NCT00293540·249 enrolled

Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer

Completed·UUniversity of Michigan Rogel Cancer Center··NCT01896050·115 enrolled

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 3·NCT00066703·2,672 enrolled

Evaluation of Tamoxifen's Efficacy for ER/PR Negative,ER-beta Positive Operable Breast Cancer Patients

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 3·NCT02062489·688 enrolled

Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer

Active, not recruiting·UUniversity of Chicago·Phase 2·NCT03879577·53 enrolled

Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·N/A·NCT01503905·600 enrolled

Tamoxifen Prediction Study in Patients With ER+ Breast Cancer

Unknown status·EErasmus Medical Center·Phase 4·NCT05525481·100 enrolled

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT02278120·672 enrolled

Investigating the Potential Role of a Novel Quadrate Combination Therapy Mifepristone(Antiprogestrone), Tamoxifen, Retinoic Acid and Cannabidiol ( Selective Cyp 26 Inhibitor) for Treating Early Breast Cancer.

Unknown status·MMahmoud Ramadan mohamed Elkazzaz·Phase 3·NCT05016349·160 enrolled

SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer

Completed·—·Phase 1·NCT00005822·21 enrolled

Breast Cancer, Sexuality and Black Cohosh

Unknown status·IIrmandade da Santa Casa de Misericordia de Sao Paulo·Phase 4·NCT02467686·60 enrolled

A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer

Recruiting·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT04985266·1,100 enrolled

HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.

Unknown status·NNational Cancer Institute, Naples·Phase 3·NCT00412022·1,294 enrolled

Post Operative Adjuvant Chemotherapy Followed by Adjuvant Tamoxifen vs Nil for Patients With Operable Breast Cancer

Unknown status·KKing Faisal Specialist Hospital & Research Center·N/A·NCT00538330·2,000 enrolled

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

Terminated· Sanofi logo

Sanofi·Phase 2·NCT04059484·367 enrolled

A Study Evaluating Megestrol Acetate Modulation in Hormone Receptor Positive Advanced Breast Cancer

Unknown status·IInstituto Nacional de Cancer, Brazil·Phase 2·NCT03024580·20 enrolled

Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia

Unknown status·—··NCT05800197·300 enrolled

Sleep and Activity Patterns in Pre-menopausal Breast Cancer Patients on Tamoxifen Using a Wrist-worn Internet of Things Device

Unknown status·SSamsung Medical Center··NCT04116827·20 enrolled

Low Dose Exemestane vs Low Dose Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.

Recruiting·AAndrea DeCensi·Phase 2·NCT06364267·140 enrolled

Efficacy of High Dose Tamoxifen to Advanced Hormone Receptor-High Expressed Breast Cancer

Completed·SSun Yat-sen University·Phase 2·NCT03045653·30 enrolled

Higher Dose Preoperative taMOxifen in Premenopausal bREast Cancer Patients

Active, not recruiting·SSeoul National University Hospital·Phase 2·NCT04997941·238 enrolled

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT02057133·198 enrolled

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)

Active, not recruiting· Roche logo

Roche·Phase 3·NCT05306340·373 enrolled

Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy.

Active, not recruiting·MMedSIR·Phase 2·NCT03161353·377 enrolled

Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer

Completed·MMedical College of Wisconsin·Phase 2·NCT03219476·37 enrolled

SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer

Completed·EEvgen Pharma·Phase 2·NCT02970682·60 enrolled

Decision Aids for Tamoxifen Treatment in Breast Cancer Patients

Unknown status·NNational Cancer Center, Korea·N/A·NCT02488603·360 enrolled

Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer

Active, not recruiting·TTolmar Inc.·Phase 3·NCT04906395·250 enrolled

Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 3·NCT00279448·9,779 enrolled

Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients

Completed·RRoswell Park Cancer Institute·N/A·NCT01027416·59 enrolled

Efficacy of Tamoxifen Versus Toremifene in CYP2D6 IM/PM of Premenopausal Patients With ER-positive Early Breast Cancer

Unknown status·CChinese Anti-Cancer Association·Phase 3·NCT03351062·844 enrolled

Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02

Completed·EETOP IBCSG Partners Foundation·Phase 3·NCT00659373·86 enrolled

Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women

Completed·NNSABP Foundation Inc·Phase 3·NCT00003906·19,747 enrolled

Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00034125

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

Recruiting·UUniversity of Chicago·Phase 2·NCT06348134·74 enrolled

Assessing the Response Rate of Neo-adjuvant Paclitaxel (Taxol) in Nigerian Women With Breast Cancer

Withdrawn·UUniversity of Chicago·Phase 2·NCT03058939

Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients

Completed·—·Phase 3·NCT02995772·122 enrolled

Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed

Completed·NNSABP Foundation Inc·Phase 3·NCT00002707·2,411 enrolled

PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY

Active, not recruiting·NNational Cancer Center, Japan·Phase 3·NCT03423199·180 enrolled

Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors

Completed·—·N/A·NCT00165308·29 enrolled

A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

Completed·UUniversity of California, San Francisco·Phase 2·NCT02384239·70 enrolled

Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer

Unknown status·IInstituto Jalisciense de Cancerologia··NCT04389424·300 enrolled

Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 3·NCT00038467·4,740 enrolled

A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Completed· Roche logo

Roche·Phase 1/2·NCT03280563·144 enrolled

Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib

Completed·SShannon Puhalla·Phase 1·NCT02913430·7 enrolled

Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer

Terminated·IInstitut Claudius Regaud·Phase 2·NCT00210028·40 enrolled

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

Recruiting·SStemline Therapeutics, Inc.·Phase 3·NCT06492616·4,220 enrolled

Open-label, Safety Extension Study for Subjects With HR+, HER2-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer OVELIA Study

Enrolling by invitation·TTolmar Inc.·Phase 3·NCT05645536·250 enrolled

Treatment4 trials

Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users

Completed·OOregon Health and Science University·Phase 4·NCT02070692·56 enrolled

Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?

Completed·TThe Alfred·Phase 2·NCT00206544·51 enrolled

Treatment Effect of Tamoxifen on Patients With DMD

Completed·HHadassah Medical Organization·Phase 1·NCT02835079·19 enrolled

Show 1 more trial

Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

Completed·OOregon Health and Science University·Phase 4·NCT02903121·109 enrolled

Premenopausal2 trials

Premenopausal Endocrine Responsive Chemotherapy Trial

Terminated·EETOP IBCSG Partners Foundation·Phase 3·NCT00066807·29 enrolled

Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients

Completed·AAustrian Breast & Colorectal Cancer Study Group·Phase 3·NCT00309478·1,099 enrolled

Amyotrophic Lateral Sclerosis2 trials

Safety and Efficacy Study of Creatine and Tamoxifen in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

Completed·NNazem Atassi·Phase 2·NCT01257581·60 enrolled

Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]

Completed·UUniversity of Wisconsin, Madison·Phase 2·NCT00214110·100 enrolled

Genetic Polymorphism2 trials

A Pilot Study of Varying Doses of Tamoxifen in the Setting of Genetic Polymorphisms of CYP2D6

Completed·IIcahn School of Medicine at Mount Sinai··NCT00900744·121 enrolled

Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen

Terminated·NNational Cancer Center, Korea·Phase 2·NCT00532454·21 enrolled

76 more indications

Adjuvant2 trials

Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women

Unknown status·FFirst Affiliated Hospital, Sun Yat-Sen University·Phase 3·NCT02914158·680 enrolled

Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant

Completed·IInstitut Claudius Regaud·Phase 2·NCT00919399·15 enrolled

Ovarian Carcinoma2 trials

REGorafenib vsTamoxifen in Patients With Platinum-sensitive OVARian Carcinoma and Isolated Biological Progression

Completed·AARCAGY/ GINECO GROUP·Phase 2·NCT02584465·68 enrolled

A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-based Therapy

Completed·AAGO Study Group·Phase 2·NCT00189358

Prevention2 trials

Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients

Completed·MMedSIR·Phase 2·NCT04300790·69 enrolled

Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection

Recruiting·UUniversity of Nebraska·Phase 1·NCT06320990·15 enrolled

Endocrine Therapy2 trials

Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance

Completed·UUniversity of Utah·Phase 2·NCT01614210·52 enrolled

Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast

Unknown status·FFirst Hospital of China Medical University··NCT04666805·1,354 enrolled

Ovarian Cancer2 trials

Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer

Active, not recruiting·AAnthony Joshua, FRACP·Phase 1·NCT05156892·44 enrolled

Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane

Completed·NNordic Society of Gynaecological Oncology - Clinical Trials Unit·Phase 3·NCT02728622·241 enrolled

Breast Disease2 trials

Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00031720·112 enrolled

Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer

Completed·MMedical College and Hospital Kolkata·Phase 4·NCT00999921·256 enrolled

Tics2 trials

Tamoxifen Pharmacogenetics and Clinical Effects

Completed·NNational Institute of General Medical Sciences (NIGMS)··NCT00228930·297 enrolled

ATAC - Pharmacokinetics (PK) Sub-Protocol

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00784862·9,358 enrolled

Esophageal Cancer1 trial

Tamoxifen in Patients With Oesophageal Cancer

Unknown status·UUniversity of Nottingham·Phase 1·NCT02513849·20 enrolled

Ductal Carcinoma in Situ1 trial

Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT00290654·45 enrolled

Ovarian Function1 trial

Evaluating the Role of the Addition of Ovarian Function Suppression (OFS) to Tamoxifen in Young Women

Unknown status·KKorean Breast Cancer Study Group·Phase 3·NCT00912548·1,234 enrolled

Recurrence1 trial

Tamoxifen Versus Etoposide After First Recurrence in GBM Patients

Recruiting·AAHS Cancer Control Alberta·Phase 2·NCT04765098·60 enrolled

Pulmonary Arterial Hypertension1 trial

Tamoxifen Therapy to Treat Pulmonary Arterial Hypertension

Completed·VVanderbilt University Medical Center·Phase 2·NCT03528902·18 enrolled

Multiple Myeloma1 trial

Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma

Completed·AAEterna Zentaris·N/A·NCT00847366·10 enrolled

Chronic Hepatitis1 trial

Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy

Completed·—·Phase 1·NCT00749138·18 enrolled

Histone Deacetylase Inhibitor1 trial

Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT03382834·31 enrolled

Bleeding1 trial

Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)

Completed·OOregon Health and Science University·Phase 4·NCT02824224·42 enrolled

Bone Density1 trial

ATAC - Bone Density Sub-Protocol

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00784940·308 enrolled

Advanced Solid Cancer1 trial

To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02093351·79 enrolled

Fibrosis1 trial

Prednisone Versus Tamoxifen in Idiopathic Retroperitoneal Fibrosis

Unknown status·UUniversity of Parma·Phase 2·NCT00440349·38 enrolled

Breast Carcinoma1 trial

Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00287534·1,059 enrolled

Ovulation Induction1 trial

Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs

Completed·—·Phase 4·NCT02479256·600 enrolled

Osteosarcoma1 trial

A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) With/Without Tamoxifen in Patients With Osteosarcoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00001436·24 enrolled

Duchenne Muscular Dystrophy1 trial

Tamoxifen in Duchenne Muscular Dystrophy

Completed·UUniversity Hospital, Basel, Switzerland·Phase 3·NCT03354039·93 enrolled

MPA1 trial

Impact of Low-dose Tamoxifen on BPU

Completed·MMayo Clinic·N/A·NCT02979301·22 enrolled

Resistance1 trial

Reversing Therapy Resistance With Epigenetic-Immune Modification

Terminated·UUniversity of California, San Francisco·Phase 2·NCT02395627·38 enrolled

Liver1 trial

Liver Safety Under Upfront Arimidex vs Tamoxifen

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00537771·384 enrolled

Analgesic Efficacy1 trial

Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia

Completed·MMansoura University·Phase 2·NCT03715413·64 enrolled

Cognition1 trial

Cognition in the Study of Tamoxifen and Raloxifene

Completed·WWake Forest University·Phase 3·NCT00687102·1,498 enrolled

ILD1 trial

Tamoxifen and Clomiphene Citrate in Mild Stimulation IVF

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 4·NCT02690870·210 enrolled

Menopausal Women1 trial

Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%

Completed·MMedSIR·Phase 2·NCT05659563·92 enrolled

Squamous Cell Carcinoma1 trial

A Trial of Tamoxifen and Letrozole in Recurrent and Persistent Squamous Cell Carcinoma of the Cervix

Unknown status·—·Phase 2·NCT02482740·44 enrolled

Bipolar I Disorder1 trial

Examination of Tamoxifen in Acute Mania in Patients With Bipolar I Disorder

Completed·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00026585·50 enrolled

Metastatic Cancer1 trial

Tamoxifen-RAD001 Versus Tamoxifen Alone in Patients With Anti-aromatase Resistant Breast Metastatic Cancer

Completed·AARCAGY/ GINECO GROUP·Phase 2·NCT01298713·111 enrolled

Cryptococcal Meningitis1 trial

Treatment With Tamoxifen in Cryptococcal Meningitis

Completed·OOxford University Clinical Research Unit, Vietnam·Phase 2·NCT03112031·50 enrolled

Pancreatic Cancer1 trial

A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

Active, not recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT06630325·30 enrolled

Fertility Preservation1 trial

Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial

Recruiting·UUniversity of California, San Francisco·Phase 3·NCT03011684·309 enrolled

Bone Metastasis1 trial

Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis

Completed·EEmory University·Phase 2·NCT03691493·36 enrolled

Hormone Receptor Positive1 trial

Study of Tamoxifen in Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression

Completed·—·Phase 2·NCT03870399·23 enrolled

Pain and Discomfort1 trial

TAmoxifen Versus LIdocaine Cream. A Randomized Clinical Trial for Reducing Pain and Discomfort During Mammography

Unknown status·UUniversidade Federal de Goias·Phase 2/3·NCT02801786·450 enrolled

MRI1 trial

Tamoxifen-MRI Study

Completed·UUniversity of Pennsylvania·Phase 2·NCT00295100·78 enrolled

Outcome1 trial

The Effect of Tamoxifen on Clinical Outcome in Women With Thin Endometrium Undergoing Frozen Thawed Cycle.

Unknown status·SSun Yat-sen University·Phase 4·NCT03060304·100 enrolled

Women1 trial

Tamoxifen Compared With Clomiphene Citrate for Women Who Had Thin Endometrium Women Under Clomiphene in a Previous Cycle

Unknown status·SShaare Zedek Medical Center·N/A·NCT00449514·100 enrolled

Quality of Life1 trial

ATAC - Quality of Life Sub-Protocol

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00784680·308 enrolled

Transitional Cell Carcinoma1 trial

Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment

Completed·SSeth Lerner·Phase 2·NCT00710970·28 enrolled

APL1 trial

Tamoxifen to Treat Barrett's Metaplasia

Terminated·WWashington University School of Medicine·Phase 1·NCT02089386·7 enrolled

SMA1 trial

Karolinska Interventional Study of Mammograhic Density (Karisma-1)

Completed·KKarolinska Institutet·Phase 1/2·NCT04079517·42 enrolled

Interaction1 trial

Open-Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Tamoxifen When Coadministered To Healthy Post-Menopausal Female Subjects

Completed· Pfizer logo

Pfizer·Phase 4·NCT01189500·30 enrolled

Postmenopausal Women1 trial

Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA

Completed·DDaré Bioscience, Inc.·Phase 1/2·NCT05378269·17 enrolled

Clinical Trial1 trial

Clinical Trial to Evaluate the Safety and Effectiveness of GDC-0032 When Given Alongside Tamoxifen

Completed·TThe Netherlands Cancer Institute·Phase 1/2·NCT02285179·189 enrolled

Intraepithelial Neoplasia1 trial

Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up

Active, not recruiting·AAndrea DeCensi·Phase 3·NCT01357772·500 enrolled

Mammographic Density1 trial

Low Dose Tamoxifen for Mammographic Density Reduction

Completed·PPer Hall·Phase 2·NCT03346200·1,440 enrolled

Drug Monitoring1 trial

Genetic Study of CYP2D6 Enzyme and Therapeutic Drug Monitoring of Tamoxifen

Unknown status·—··NCT03582865·100 enrolled

Breast Neoplasm1 trial

Long-term Follow-up of the TAM-01 Study and Pooled Analysis of Low-dose Tamoxifen Studies in Non-invasive or Microinvasive Breast Neoplasms

Completed·EEnte Ospedaliero Ospedali Galliera··NCT06982313·1,545 enrolled

Absorption1 trial

A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT01821066·25 enrolled

Ductal Carcinoma1 trial

Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ

Recruiting·IInstitut Cancerologie de l'Ouest·Phase 2·NCT04666961·262 enrolled

Advanced1 trial

Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

Recruiting·FFudan University·Phase 2·NCT06914674·30 enrolled

DLBCL1 trial

Maintenance Hormonal Therapy and DLBCL

Not yet recruiting·SSohag University·Phase 2/3·NCT06355401·100 enrolled

Endometrial1 trial

ATAC - Endometrial Sub-Protocol

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00814125·285 enrolled

Observational Study1 trial

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

Unknown status·—··NCT04852081·1,000 enrolled

Metastatic1 trial

Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00229697·317 enrolled

Hereditary Hemorrhagic Telangiectasia1 trial

Anti-Estrogen Therapy for Hereditary Hemorrhagic Telangiectasia A Double-Blind Placebo-Controlled Clinical Trial

Completed·RRabin Medical Center·Phase 2·NCT00375622·60 enrolled

Hormone Replacement Therapy1 trial

Phase III, Randomized, Double Blind Trial Low Dose Tamoxifen Versus Placebo in Hormone Replacement Therapy (HRT) Users

Unknown status·EEuropean Institute of Oncology·Phase 3·NCT01579734·1,884 enrolled

Endometrial Cancer1 trial

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer

Completed·GGOG Foundation·Phase 2·NCT02228681·74 enrolled

Chemotherapy1 trial

A Phase 2 Study of the IDO Inhibitor Epacadostat Versus Tamoxifen for Subjects With Biochemical-recurrent-only EOC, PPC or FTC Following Complete Remission With First-line Chemotherapy

Terminated· Incyte logo

Incyte·Phase 2·NCT01685255·83 enrolled

Advanced Cancer1 trial

A Study of LY2228820 in Participants With Advanced Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01393990·89 enrolled

Breast Ductal Carcinoma in Situ1 trial

A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)

Terminated·UUniversity of Southern California·Phase 2·NCT00183963·4 enrolled

Obesity1 trial

Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT01758146·412 enrolled

Prostate Cancer1 trial

Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00233610·180 enrolled

Metastatic Breast Cancer1 trial

A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study

Active, not recruiting· Novartis logo

Novartis·Approved·NCT05161195·134 enrolled

ER Positive Breast Cancer1 trial

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse

Recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT05512364·220 enrolled

BRCA Mutation1 trial

Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion: a Randomized Phase II Biomarker Trial in Subjects at Increased Risk

Completed·EEuropean Institute of Oncology·Phase 2·NCT06033092·110 enrolled

Invasive Breast Carcinoma1 trial

SHORTened Duration of TAMoxifen for Risk Reduction in Breast Intraepithelial Neoplasms in Post-menopausal Women

Active, not recruiting·RRutgers, The State University of New Jersey·Phase 2·NCT07806630·250 enrolled

Breast Neoplasms1 trial

preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07287098·600 enrolled

Anatomic Stage 0 Breast Cancer AJCC v81 trial

LoTam: A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients With Molecular Low-Risk Early-Stage Breast Cancer

Suspended·AAlliance for Clinical Trials in Oncology·Phase 3·NCT06671912·1,556 enrolled

Breast Atypical Hyperplasia1 trial

Phase IIB Randomized Trial of Oral Tamoxifen vs. Topical 4-hydroxytamoxifen Gel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma in Situ, or Increased Breast Cancer Risk

Terminated·MMayo Clinic·Phase 2·NCT04570956·65 enrolled

Unspecified6 trials

Casodex - Nolvadex Combination

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00637871

CYP2D6 Genotype on the Clinical Effect of Tamoxifen

Unknown status·KKorea University Anam Hospital··NCT00973037·922 enrolled

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

Completed·AAustrian Breast & Colorectal Cancer Study Group·Phase 3·NCT00295646·1,803 enrolled

Show 3 more trials

Therapeutic Dose Monitoring (TDM) of Tamoxifen

Unknown status·KKarolinska University Hospital·Phase 2·NCT05133674·40 enrolled

ATAC - Arimidex, Tamoxifen Alone or in Combination

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00849030·9,358 enrolled

Tamoxifen Study

Completed·NNSABP Foundation Inc·Phase 3·NCT00000529

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

NOLVADEX

NDA NDA017970

Oct 29, 2005

SOLTAMOX

NDA NDA021807

Sources

References

[1]
ClinicalTrials.gov — 219 trial records for Tamoxifen. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nolvadex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tamoxifen compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tamoxifen. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021807). U.S. Food & Drug Administration.
[6]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Estrogen Receptor Alpha Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AstraZeneca