Hormone · Profile

Tamoxifen

Nolvadex · TAM · SERM

Hormone ManagementApproved

MW: 371.5g/mol
Formula: C26H29NO

Tamoxifen is a selective estrogen receptor modulator (SERM) primarily used in the management of breast cancer, acting on estrogen receptors found in various tissues, including the breast and retina. Researchers primarily study tamoxifen for its efficacy in treating estrogen receptor-positive breast cancer and its associated side effects. Key findings indicate that tamoxifen can lead to retinal toxicity, with an incidence ranging from 0.9% to 12%, and that resistance to tamoxifen in breast cancer cells may be linked to the inhibition of ferroptosis by RelB and glutathione peroxidase 4 (GPX4). Current research continues to explore the optimal duration of tamoxifen therapy and its comparative effectiveness against newer treatments, while also investigating its potential thromboembolic risks. Clinical evidence indicates that despite its established benefits, monitoring for adverse effects remains crucial in the management of patients undergoing tamoxifen therapy.

Overview

Übersicht

Tamoxifen, commonly known by its trade name Nolvadex, is a synthetic compound classified as a selective estrogen receptor modulator (SERM). It is not naturally occurring and is chemically synthesized for therapeutic use. Tamoxifen is primarily used in the management of hormone receptor-positive breast cancer. Researchers have found that tamoxifen acts by binding to estrogen receptors, thereby inhibiting estrogen's proliferative action on breast tissue. This mechanism is particularly beneficial in treating and preventing breast cancer in both pre- and postmenopausal women. The primary physiological role of tamoxifen is to modulate estrogen receptor activity, which is crucial in breast cancer treatment. It is also being researched for its effects on other estrogen-sensitive tissues, such as the retina, where it can cause retinopathy, and its role in inducing or resisting ferroptosis in cancer cells. Tamoxifen's mechanism of action involves competitive inhibition of the estrogen receptor signaling pathway, which leads to decreased cellular proliferation in estrogen receptor-positive breast cancer cells. Researchers have observed that tamoxifen resistance can occur through pathways such as RelB-activated GPX4, which inhibits ferroptosis. Pharmacokinetically, tamoxifen is well absorbed orally, with a half-life of approximately 5 to 7 days due to its extensive enterohepatic circulation and metabolism primarily by the liver. It undergoes biotransformation to active metabolites, including 4-hydroxytamoxifen and endoxifen, which contribute to its therapeutic effects. Clinically, tamoxifen is widely used for the treatment and prevention of breast cancer, including ductal carcinoma in situ and for chemoprevention in high-risk individuals. It is approved by regulatory agencies worldwide, including the FDA, and is considered a prescription medication. Ongoing research continues to explore its optimal duration of use and comparison with newer therapies like aromatase inhibitors.

Chemical profile

Chemische Struktur

Formel	C26H29NO
Molekulargewicht	371.5g/mol
CAS-Nummer	10540-29-1
PubChem CID	2733526

Mechanism

Wirkmechanismus

Tamoxifen acts on estrogen receptors as a selective estrogen receptor modulator (SERM). By binding to these receptors, it blocks estrogen from exerting its effects on breast tissue, thereby inhibiting cell proliferation and tumor growth. This action is crucial in the treatment of estrogen receptor-positive breast cancer.

Mechanism

Signalweg

Tamoxifen (TAM) acts primarily as a selective estrogen receptor modulator (SERM), binding to estrogen receptors (ERs) in breast tissue, thereby inhibiting estrogen-mediated signaling pathways that promote tumor growth. Additionally, TAM influences the regulation of reactive oxygen species (ROS) and ferroptosis through the transcriptional activation of RelB and glutathione peroxidase 4 (GPX4), contributing to its pharmacodynamics and resistance mechanisms in breast cancer cells. While its primary action is well-defined, the complete understanding of all downstream signaling pathways and biological processes affected by TAM remains an area of ongoing research.

Half-Life & Pharmacokinetics

POOral

Approximately 5 to 7 days due to extensive enterohepatic circulation

Tamoxifen is metabolized to active metabolites such as 4-hydroxytamoxifen and endoxifen, which contribute to its long half-life.

Storage

Temperature

Store at room temperature (15-30C)

Light

Protect from light

Form

Typically available in tablet form

Notes

Ensure the medication is kept in a dry place to maintain stability.

Solubility

Löslichkeit

Tamoxifen is poorly soluble in water but soluble in ethanol and other organic solvents.

Legal Status

🇩🇪DE

Verschreibungspflichtig (prescription only); not a controlled substance under BtMG.

🇺🇸US

FDA approved for breast cancer treatment and prevention; prescription required.

🇦🇺AU

Schedule 4 (S4) prescription only medicine.

🇬🇧UK

Prescription Only Medicine (POM); regulated by the MHRA.

Legal status information is provided for general reference only and may not reflect the most current regulatory changes. Always verify with official government sources before making any decisions.

Open Questions

Offene Forschungsfragen

Current evidence is limited regarding the optimal screening modalities for tamoxifen-induced retinal toxicity, as existing methods have not proven effective for early detection. Further research is needed to establish standardized protocols for monitoring retinal health in patients undergoing tamoxifen therapy, including larger longitudinal studies to assess the long-term effects of tamoxifen on retinal function. Additionally, the mechanisms underlying tamoxifen resistance, particularly the role of ferroptosis and the influence of factors like RelB and GPX4, require more extensive investigation, including randomized controlled trials in diverse patient populations to validate these findings and explore potential therapeutic interventions.

96 Research Publications

2,018

Total Citations

Human/RCT

2.1

Avg. Influence

2026

Latest

Sort

Filter

01Top

#01

Tamoxifen ("Nolvadex"): a review.

Clemons M, et al. · Cancer treatment reviews · 2002

ReviewInfluence6.0

222

The review highlighted that tamoxifen remains the hormonal treatment of choice for estrogen-receptor positive breast cancer due to its efficacy and tolerability in both pre- and postmenopausal women.

Key findings

01Tamoxifen is effective for both early and advanced breast cancer.
02It works well for both pre- and postmenopausal women.
03Ongoing studies are exploring the best duration of treatment and comparisons with newer therapies.

PubMed

02Top

#02

Tumor-associated macrophages secrete CC-chemokine ligand 2 and induce tamoxifen resistance by activating PI3K/Akt/mTOR in breast cancer.

In VitroInfluence8.0

208

Researchers observed that tumor-associated macrophages secrete CCL2, which activates the PI3K/Akt/mTOR pathway and induces tamoxifen resistance in breast cancer.

PubMed

03Top

#03

Tamoxifen resistance in breast cancer.

ReviewInfluence9.0

165

Researchers observed that tamoxifen resistance in breast cancer may arise from multiple mechanisms, including altered growth factor production and changes in estrogen receptor dynamics.

PubMed

#04

RelB-activated GPX4 inhibits ferroptosis and confers tamoxifen resistance in breast cancer.

Xu Zhi, et al. · Redox biology · 2023

In VitroInfluence1.0

The study demonstrated that RelB upregulates GPX4 to inhibit ferroptosis, contributing to tamoxifen resistance in breast cancer cells.

Key findings

01RelB contributes to tamoxifen resistance in breast cancer by inhibiting ferroptosis.
02Higher levels of RelB and GPX4 in sensitive cells increase resistance to tamoxifen.
03Decreasing RelB and GPX4 in resistant cells enhances their sensitivity to tamoxifen.

PubMed

#05

Novel Tamoxifen Nanoformulations for Improving Breast Cancer Treatment: Old Wine in New Bottles.

ReviewInfluence3.0

Researchers observed that novel tamoxifen nanoformulations can selectively deliver lower doses of tamoxifen to breast tumors, potentially reducing toxicity while maintaining therapeutic efficacy.

PubMed

#06

Aromatase inhibitors alone or sequentially combined with tamoxifen in postmenopausal early breast cancer compared with tamoxifen or placebo - Meta-analyses on efficacy and adverse events based on randomized clinical trials.

ReviewInfluence1.0

Researchers observed that aromatase inhibitors outperform tamoxifen in disease-free survival for postmenopausal women with estrogen receptor-positive breast cancer.

PubMed

#07

The Christie Hospital tamoxifen (Nolvadex) adjuvant trial for operable breast carcinoma--7-yr results.

HumanInfluence2.0

Researchers observed that tamoxifen treatment significantly delayed first relapse in breast cancer patients, particularly in postmenopausal women, despite no overall survival difference at the 7-year mark.

PubMed

#08

Mitochondria: the gateway for tamoxifen-induced liver injury.

ReviewInfluence4.0

Researchers observed that tamoxifen induces liver injury through mitochondrial dysfunction, highlighting the need for therapeutic drug monitoring in patients.

PubMed

#09

Cholesterol metabolism and resistance to tamoxifen.

In Vitro

Researchers observed that the oncoprotein MUC-1 correlates with tamoxifen resistance in breast cancer by upregulating cholesterol and lipid metabolic enzymes.

PubMed

#10

Genotoxic mechanism of tamoxifen in developing endometrial cancer.

Human

Researchers observed that tamoxifen induces genotoxic DNA damage in the endometrium, leading to increased risk of endometrial cancer in women treated with the drug.

PubMed

Clinical Trials (100)

Preclinical

Phase I

Phase II

Phase III

Approved

100

Total Trials

65,495

Total Enrolled

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

NCT04852081UNKNOWN

Sponsor

Blokhin's Russian Cancer Research Center

Enrollment

1,000

Started

2021

Primary outcome

To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Moscow

Breast Cancer Stage IV

CYP2D6 Genotype on the Clinical Effect of Tamoxifen

NCT00973037UNKNOWN

Sponsor

Korea University Anam Hospital

Enrollment

922

Started

2009

Primary outcome

Disease-free survival(DFS)

Breast NeoplasmsTamoxifenGenotypeCYP2D6

Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast

NCT00126464UNKNOWN

Sponsor

Cedars-Sinai Medical Center

Enrollment

100

Started

2004

Primary outcome

Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks

Breast Cancer

Genetic Study of CYP2D6 Enzyme and Therapeutic Drug Monitoring of Tamoxifen

NCT03582865UNKNOWN

Sponsor

Assiut University

Enrollment

100

Started

2019

Primary outcome

Estimate the frequency of Cyp2D6*1 and *4 alleles in Egyptian patients maintained on tamoxifen (20 mg/day) for management of ER +ve breast cancer.

Breast Cancer

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

NCT01027416COMPLETED

Sponsor

Roswell Park Cancer Institute

Enrollment

Started

2009

Primary outcome

Mean Percent Positive Proximity Ligation Assays of All Tumor Protein p53-wild Type Breast Tumors in Participants by Treatment Arm

Breast Cancer

Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer

NCT01293032COMPLETED

Sponsor

Virginia Commonwealth University

Enrollment

Started

2011

Primary outcome

The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment

Ductal Breast Carcinoma in SituLobular Breast Carcinoma in SituStage II Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage IIIA Breast CancerStage IIIB Breast Cancer

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

NCT01169792COMPLETED

Sponsor

Yonsei University

Primary outcome

The frequency of the genetic polymorphisms of CYP2D6 in breast cancer patients

Breast NeoplasmsSurvival AnalysisAntineoplastic AgentsTherapeutic Uses

Roll-over Study to Allow Continued Access to Ribociclib

NCT05161195Phase 4ACTIVE_NOT_RECRUITING

Sponsor

Novartis Pharmaceuticals

Enrollment

134

Started

2022

Primary outcome

Percentage of participants with treatment-emergent adverse events (AES)

Metastatic Breast Cancer

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

NCT03060304Phase 4UNKNOWN

Sponsor

Sun Yat-sen University

Enrollment

100

Started

2017

Primary outcome

endometrium thickness

Endometrium

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

NCT02824224Phase 4COMPLETED

Sponsor

Oregon Health and Science University

Enrollment

Started

2016

Primary outcome

Number of Bleeding and Spotting Days

MenorrhagiaMetrorrhagiaMedicated Intrauterine Devices

Tamoxifen in Treating Women With Breast Cancer

NCT00003678Phase 3UNKNOWN

Sponsor

University Hospital Birmingham

Enrollment

20,000

Started

1991

Primary outcome

All-cause mortality

Breast Cancer

ATAC - Arimidex, Tamoxifen Alone or in Combination

NCT00849030Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

9,358

Started

1996

Primary outcome

Time to recurrence of breast cancer

Breast Cancer

Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer

NCT00002582Phase 3COMPLETED

Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

6,000

Started

1993

Breast Cancer

Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer

NCT00005970Phase 3COMPLETED

Sponsor

National Cancer Institute (NCI)

Enrollment

3,436

Started

2000

Primary outcome

Duration of DFS

Breast AdenocarcinomaHER2 Positive Breast CarcinomaStage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7Stage IIIA Breast Cancer AJCC v7

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

NCT00066690Phase 3COMPLETED

Sponsor

ETOP IBCSG Partners Foundation

Enrollment

3,066

Started

2003

Primary outcome

Disease-free Survival

Estrogen Receptor Positive Breast CancerProgesterone Receptor Positive TumorRecurrent Breast CarcinomaStage IA Breast CancerStage IB Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage IIIA Breast Cancer

Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer

NCT05780567Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

1,946

Started

2023

Primary outcome

Invasive Disease-Free Survival (IDFS)

Breast Cancer

Cognition in the Study of Tamoxifen and Raloxifene

NCT00687102Phase 3COMPLETED

Sponsor

Wake Forest University

Enrollment

1,498

Started

2001

Primary outcome

Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group

CognitionAging

Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer

NCT00002581Phase 3COMPLETED

Sponsor

Scottish Cancer Therapy Network

Enrollment

1,000

Started

1993

Breast Cancer

The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

NCT00097344Phase 3TERMINATED

Sponsor

Intarcia Therapeutics

Enrollment

842

Started

2004

Primary outcome

Time to progression

Breast NeoplasmsNeoplasms, Hormone-Dependent

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

NCT05891093Phase 3RECRUITING

Sponsor

Fudan University

Enrollment

766

Started

2023

Primary outcome

invasive disease free survival (iDFS)

Breast Cancer

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

NCT02062489Phase 3UNKNOWN

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

688

Started

2014

Primary outcome

Disease-free survival of patients

Breast Cancer

Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women

NCT02914158Phase 3UNKNOWN

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Enrollment

680

Started

2016

Primary outcome

Disease-Free Survival (DFS)

Breast Cancer

The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)

NCT00152178Phase 3COMPLETED

Sponsor

Taiho Pharmaceutical Co., Ltd.

Enrollment

680

Started

1996

Primary outcome

Relapse-free survival

Breast Cancer

Adjuvant AI Combined With Zoladex

NCT01352091Phase 3UNKNOWN

Sponsor

Fudan University

Enrollment

670

Started

2008

Primary outcome

DFS

Breast Cancer

Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer

NCT00002720Phase 3COMPLETED

Sponsor

European Institute of Oncology

Enrollment

642

Started

1995

Breast Cancer

Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ

NCT00003857Phase 3COMPLETED

Sponsor

Radiation Therapy Oncology Group

Enrollment

636

Started

1999

Primary outcome

Local recurrence (e.g., invasive or noninvasive recurrence)

Breast Cancer

Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery

NCT07762885Phase 3RECRUITING

Sponsor

Fudan University

Enrollment

636

Started

2026

Primary outcome

Ipsilateral Breast Tumor Recurrence (IBTR)

Ductal Carcinoma In Situ, DCIS

Combination Chemotherapy in Treating Women With Breast Cancer

NCT00003679Phase 3UNKNOWN

Sponsor

Scottish Cancer Therapy Network

Enrollment

350

Started

1998

Breast Cancer

S9630, Medroxyprogesterone in Treating Women With Breast Cancer

NCT00002920Phase 3COMPLETED

Sponsor

SWOG Cancer Research Network

Enrollment

313

Started

1997

Primary outcome

Endometrial pathologic diagnosis

Breast CancerEndometrial Cancer

ATAC - Bone Density Sub-Protocol

NCT00784940Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

308

Started

1998

Primary outcome

Time to withdrawal

Bone Density

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

NCT03137368Phase 3UNKNOWN

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

300

Started

2018

Primary outcome

Disease free survival (DFS)

CYP2D6 Polymorphism

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage II or Stage IIIA Breast Cancer

NCT00003972Phase 3COMPLETED

Sponsor

Fred Hutchinson Cancer Center

Enrollment

280

Started

1998

Breast Cancer

Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer

NCT04906395Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Tolmar Inc.

Enrollment

250

Started

2021

Primary outcome

Suppression of ovarian function

Breast Cancer

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

NCT00293540Phase 3COMPLETED

Sponsor

International Breast Cancer Research Foundation

Enrollment

249

Started

2006

Primary outcome

Overall Survival

Breast Cancer

High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer

NCT00003032Phase 3COMPLETED

Sponsor

NCIC Clinical Trials Group

Enrollment

224

Started

1997

Breast Cancer

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

NCT00605267Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

197

Started

2007

Primary outcome

Best Overall Response Rate (BORR) (Calliper)

Breast Cancer

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

NCT00233610Phase 3COMPLETED

Sponsor

AstraZeneca

Enrollment

180

Started

2003

Primary outcome

Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.

Prostate Cancer

Tamoxifen Citrate in Patients With Breast Cancer

NCT00963209Phase 3UNKNOWN

Sponsor

Centre Hospitalier Universitaire Vaudois

Enrollment

140

Started

2009

Primary outcome

Determination of CYP2D6 genotype and determination of plasma concentrations of tamoxifen citrate and its metabolites (N-desmethyl-tamoxifen, 4-hydroxy-tamoxifen and endoxifen) under the 20 mg daily and 40 mg daily schedules

Breast Cancer

Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

NCT00041080Phase 3COMPLETED

Sponsor

National Cancer Institute (NCI)

Enrollment

139

Started

2003

Primary outcome

Median Progression-free Survival

Fallopian Tube CancerPrimary Peritoneal Cavity CancerRecurrent Ovarian Epithelial CancerStage III Ovarian Epithelial CancerStage IV Ovarian Epithelial Cancer

PreOperative Endocrine Therapy for Individualised Care With Abemaciclib

NCT04584853Phase 3ACTIVE_NOT_RECRUITING

Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

123

Started

2020

Primary outcome

Time to tumour (local or distant disease) recurrence

Breast Cancer Female

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

NCT02995772Phase 3COMPLETED

Sponsor

Dharmais National Cancer Center Hospital

Enrollment

122

Started

2011

Primary outcome

Overall survival

Breast Cancer

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

NCT01638247Phase 3COMPLETED

Sponsor

GBG Forschungs GmbH

Enrollment

Started

2012

Primary outcome

Estradiol blood concentation

Male Breast Cancer

Octreotide, Tamoxifen, and Chemotherapy in Treating Women With Breast Cancer

NCT00002967Phase 3COMPLETED

Sponsor

NSABP Foundation Inc

Started

1997

Breast Cancer

Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes

NCT00004125Phase 3COMPLETED

Sponsor

Eastern Cooperative Oncology Group

Started

1999

Breast Cancer

Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer

NCT00010322Phase 3TERMINATED

Sponsor

Intarcia Therapeutics

Started

2000

Breast Cancer

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

NCT00034125Phase 3COMPLETED

Sponsor

Eli Lilly and Company

Breast Neoplasms

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

NCT02101788Phase 2/3COMPLETED

Sponsor

National Cancer Institute (NCI)

Enrollment

260

Started

2014

Primary outcome

Progression-free Survival (PFS)

Borderline Ovarian Serous TumorMicropapillary Serous CarcinomaOvarian Serous AdenocarcinomaPrimary Peritoneal Serous AdenocarcinomaRecurrent Ovarian Low Grade Serous AdenocarcinomaRecurrent Primary Peritoneal Serous Adenocarcinoma

Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study

NCT07581834Phase 2RECRUITING

Sponsor

Fujian Cancer Hospital

Enrollment

2,000

Started

2026

Primary outcome

3-year invasive disease-free survival

Breast DiseasesBreast NeoplasmsDalpiciclibEndocrine Breast DiseasesCDK4/6 InhibitorHR+/HER2- Breast Cancer

A Randomized Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer

NCT01771458Phase 2COMPLETED

Sponsor

Institut Curie

Enrollment

742

Started

2012

Primary outcome

Patient's progression free survival (according RECIST 1.1) of targeted therapy based on molecular profiling versus conventional chemotherapy.

Reccurent/Metastatic Solid Tumor Disease

Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen

NCT00764322Phase 2COMPLETED

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

501

Started

2008

Primary outcome

Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes

Breast CancerMenopausal Symptoms

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

NCT03161353Phase 2ACTIVE_NOT_RECRUITING

Sponsor

MedSIR

Enrollment

377

Started

2017

Primary outcome

Evaluate the rate of pCR

Breast Cancer

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

NCT00229697Phase 2COMPLETED

Sponsor

AstraZeneca

Enrollment

317

Started

2003

Primary outcome

Strata 1: To compare the time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)

Breast Neoplasms

Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer

NCT00738777Phase 2SUSPENDED

Sponsor

The Netherlands Cancer Institute

Enrollment

250

Started

2008

Primary outcome

Decrease in tumor cell proliferation and induced apoptosis.

Breast Cancer

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

NCT02747004Phase 2ACTIVE_NOT_RECRUITING

Sponsor

Eli Lilly and Company

Enrollment

234

Started

2016

Primary outcome

Progression Free Survival (PFS)

Metastatic Breast Cancer

Combination Therapy With Isotretinoin and Tamoxifen Expected to Provide Complete Protection Against Severe Acute Respiratory Syndrome Coronavirus

NCT04389580Phase 2UNKNOWN

Sponsor

Kafrelsheikh University

Enrollment

160

Started

2021

Primary outcome

lung injury score

COVID-19

Neu Direction: Testing the Efficacy of Adding HER Inhibition to Standard of Care in Metastatic MLH1-low Endocrine-resistant ER+/HER2- Breast Cancer

NCT07729046Phase 2NOT_YET_RECRUITING

Sponsor

University of California, San Diego

Enrollment

150

Started

2027

Primary outcome

Median Progression-Free Survival

Metastatic Invasive Breast CancerResistant Breast CancerER+, HER2-, Metastatic Breast Cancer

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

NCT06364267Phase 2RECRUITING

Sponsor

Andrea DeCensi

Enrollment

140

Started

2025

Primary outcome

Quality of life MEnQol

Breast Cancer

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

NCT00031720Phase 2COMPLETED

Sponsor

Alliance for Clinical Trials in Oncology

Enrollment

112

Started

2002

Primary outcome

Change in number of daily hot flushes at 3 months from baseline

Breast CancerHot FlashesHot Flushes

Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]

NCT00214110Phase 2COMPLETED

Sponsor

University of Wisconsin, Madison

Enrollment

100

Started

2001

Primary outcome

Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength

Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients

NCT07535905Phase 2NOT_YET_RECRUITING

Sponsor

University Health Network, Toronto

Enrollment

Started

2026

Primary outcome

Normal Testosterone Recovery

HypogonadismProstate Cancer

Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer

NCT05982093Phase 2RECRUITING

Sponsor

SOLTI Breast Cancer Research Group

Enrollment

Started

2023

Primary outcome

To evaluate the biological activity of elacestrant with or without OFS in premenopausal women with ER+/HER2- operable EBC

Breast CancerHER2-negative Breast CancerHormone Receptor Positive TumorPremenopausal Breast Cancer

Docetaxel, Epirubicin, and Cyclophosphamide With or Without Trastuzumab in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

NCT00398489Phase 2UNKNOWN

Sponsor

Technical University of Munich

Enrollment

Started

2006

Primary outcome

Rate of pathologic complete remission (pCR) after neoadjuvant therapy comprising docetaxel and trastuzumab (Herceptin®) in women with locally advanced, HER2-positive, operable breast cancer

Breast Cancer

Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors

NCT01196936Phase 2ACTIVE_NOT_RECRUITING

Sponsor

University of Alabama at Birmingham

Enrollment

Started

2010

Primary outcome

Mammographic Breast Density

Breast Cancer

Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer

NCT04272801Phase 2ACTIVE_NOT_RECRUITING

Sponsor

Shayna Showalter, MD

Enrollment

Started

2020

Primary outcome

Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment

Breast Cancer Female

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

NCT03211572Phase 2UNKNOWN

Sponsor

Ottawa Hospital Research Institute

Enrollment

Started

2017

Primary outcome

Endocrine Therapy response

Breast Cancer

Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas

NCT00492687Phase 2UNKNOWN

Sponsor

San Diego Pacific Oncology & Hematology Associates

Enrollment

Started

2006

Primary outcome

Progression-free survival

Brain and Central Nervous System Tumors

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer

NCT02228681Phase 2COMPLETED

Sponsor

GOG Foundation

Enrollment

Started

2015

Primary outcome

Frequency of Response

Advanced, Persistent, or Recurrent Endometrial Cancer

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

NCT06348134Phase 2RECRUITING

Sponsor

University of Chicago

Enrollment

Started

2025

Primary outcome

Pathological Complete Response

Human Epidermal Growth Factor 2 Negative Carcinoma of BreastHER2-positive Breast CancerBreast Cancer

Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

NCT00068419Phase 2COMPLETED

Sponsor

Children's Oncology Group

Enrollment

Started

2004

Primary outcome

Percentage of Patients Failure Free at 2 Years Following Study Entry

Desmoid Tumor

Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction

NCT06195306Phase 2RECRUITING

Sponsor

National Cancer Institute (NCI)

Enrollment

Started

2025

Primary outcome

Change in serum adiponectin

Breast Atypical HyperplasiaBreast CarcinomaBreast Ductal Carcinoma In SituBreast Lobular Carcinoma In Situ

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

NCT02970682Phase 2COMPLETED

Sponsor

Evgen Pharma

Enrollment

Started

2016

Primary outcome

Treatment-Emergent Adverse Events [Safety and Tolerability])

Breast Neoplasm

Tamoxifen Versus Etoposide After First Recurrence in GBM Patients

NCT04765098Phase 2RECRUITING

Sponsor

AHS Cancer Control Alberta

Enrollment

Started

2022

Primary outcome

3 month progression-free survival

Glioblastoma Multiforme

Chemoprevention Therapy Plus Surgery in Treating Women With Breast Cancer

NCT00003099Phase 2COMPLETED

Sponsor

M.D. Anderson Cancer Center

Enrollment

Started

1996

Primary outcome

Fenretinide + Tamoxifen effectiveness given before surgery in treating breast cancer

Breast Cancer

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

NCT00206544Phase 2COMPLETED

Sponsor

The Alfred

Enrollment

Started

2004

Primary outcome

Scores on CARS-M Scale at trial completion

Bipolar DisorderManiaSchizoaffective Disorder

Tamoxifen, Carboplatin, and Topotecan in Treating Patients With CNS Metastases or Recurrent Brain or Spinal Cord Tumors

NCT00541138Phase 2COMPLETED

Sponsor

City of Hope Medical Center

Enrollment

Started

2003

Primary outcome

Toxicity profile as assessed by NCI CTC v2.0

Brain and Central Nervous System TumorsMetastatic CancerUnspecified Adult Solid Tumor, Protocol Specific

Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery

NCT00194779Phase 2COMPLETED

Sponsor

University of Washington

Enrollment

Started

2003

Primary outcome

Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)

Estrogen Receptor-negative Breast CancerEstrogen Receptor-positive Breast CancerHER2-positive Breast CancerProgesterone Receptor-negative Breast CancerProgesterone Receptor-positive Breast CancerStage IA Breast CancerStage IB Breast CancerStage II Breast CancerStage IIIA Breast Cancer

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

NCT02404844Phase 2COMPLETED

Sponsor

University Hospital, Essen

Enrollment

Started

2014

Primary outcome

Progression free survival (PFS)-rate in the full population, after 6 months

Breast Cancer

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

NCT02482740Phase 2UNKNOWN

Sponsor

Buddhist Tzu Chi General Hospital

Enrollment

Started

2015

Primary outcome

The response rate

Uterine Cervical Neoplasms

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

NCT00210028Phase 2TERMINATED

Sponsor

Institut Claudius Regaud

Enrollment

Started

2003

Primary outcome

To evaluate the objective response rate when ZARNESTRA is added to administration of tamoxifen in patients suffering from metastatic or advanced inoperable breast cancer, who are progressing on tamoxifen treatment

Breast Neoplasms

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

NCT03219476Phase 2COMPLETED

Sponsor

Medical College of Wisconsin

Enrollment

Started

2017

Primary outcome

Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy.

Breast CancerInvasive Breast Cancer

Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.

NCT07289035Phase 2NOT_YET_RECRUITING

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Enrollment

Started

2026

Primary outcome

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Cystic Fibrosis - Complete

Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

NCT06914674Phase 2RECRUITING

Sponsor

Fudan University

Enrollment

Started

2025

Primary outcome

Progression-free survival (PFSn)

Pancreatic Neoplasms

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

NCT02988986Phase 2COMPLETED

Sponsor

The Methodist Hospital Research Institute

Enrollment

Started

2017

Primary outcome

Ki67 Expression

Estrogen Receptor Positive Breast Cancer

Paclitaxel, Cyclophosphamide & Doxorubicin, Autologous Dendritic Cells & Surgery in Stage II/III Breast Cancer (Women)

NCT00499083Phase 2COMPLETED

Sponsor

University of Nebraska

Enrollment

Started

2006

Primary outcome

Number of Patients With Pathological Complete Response

Breast Cancer

Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant

NCT00919399Phase 2COMPLETED

Sponsor

Institut Claudius Regaud

Enrollment

Started

2002

Primary outcome

Evaluate the objective response rate (complete response and partial response)

Breast Neoplasms

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

NCT02322853Phase 2TERMINATED

Sponsor

Centre Francois Baclesse

Enrollment

Started

2015

Primary outcome

To define the efficacy (progression-free survival rate at 6 months) of LY2228820 in combination with tamoxifen for postmenopausal women with an ER positive and HER2 negative advanced or metastatic breast cancer who progressed on aromatase inhibitors.

PostmenopausalMetastatic Breast Cancer

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

NCT00206492Phase 2TERMINATED

Sponsor

Baylor Breast Care Center

Enrollment

Started

2003

Primary outcome

cellular response

Breast Cancer

A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

NCT01194427Phase 2TERMINATED

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

Started

2011

Primary outcome

Changes in Markers of Proliferation Prior to and After Study Drug Administration

Stage I Breast CancerStage II Breast CancerStage III Breast CancerInvasive Breast Cancer

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

NCT04190056Phase 2TERMINATED

Sponsor

University of California, San Francisco

Enrollment

Started

2021

Primary outcome

Overall Response Rate (ORR)

Anatomic Stage IV Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8

Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma

NCT00024336Phase 2UNKNOWN

Sponsor

Children's Cancer and Leukaemia Group

Started

1999

Brain and Central Nervous System Tumors

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

NCT00189358Phase 2COMPLETED

Sponsor

AGO Study Group

Primary outcome

Safety and tolerability

Ovarian CancerCancer of the Fallopian TubePeritoneal Cancer

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

NCT03280563Phase 1/2COMPLETED

Sponsor

Hoffmann-La Roche

Enrollment

144

Started

2017

Primary outcome

Stage 1: Percentage of Participants With Objective Response

Breast Neoplasms

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

NCT04961632Phase 1UNKNOWN

Sponsor

National Cancer Centre, Singapore

Enrollment

Started

2020

Primary outcome

Endoxifen blood concentration

Breast Cancer

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

NCT01821066Phase 1COMPLETED

Sponsor

Pfizer

Enrollment

Started

2013

Primary outcome

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PD-0332991

Healthy

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

NCT00001436Phase 1COMPLETED

Sponsor

National Cancer Institute (NCI)

Enrollment

Started

1995

Neoplasm MetastasisOsteosarcoma

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

NCT00005822Phase 1COMPLETED

Sponsor

Case Comprehensive Cancer Center

Enrollment

Started

2000

Primary outcome

Determine the maximum tolerated dose of SU5416 and doxorubicin in patients with stage IIIB or IV inflammatory breast cancer.

Breast Cancer

Lapatinib and Tamoxifen in Treating Patients With Advanced or Metastatic Breast Cancer

NCT00424164Phase 1COMPLETED

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

Started

2006

Primary outcome

Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination

Breast Cancer

Treatment Effect of Tamoxifen on Patients With DMD

NCT02835079Phase 1COMPLETED

Sponsor

Hadassah Medical Organization

Enrollment

Started

2016

Primary outcome

6-minute walk distance (6MWD)

Duchenne Muscular Dystrophy

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

NCT02936206Phase 1TERMINATED

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

Started

2016

Primary outcome

Change in Ki67 Cell Percentage

Breast Cancer

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Persistent or Platinum Refractory Stage III or IV Ovarian Cancer

NCT00003080Phase 1COMPLETED

Sponsor

Fred Hutchinson Cancer Center

Started

1996

Ovarian Cancer

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