Tamoxifen

Generic Name: Tamoxifen

Brand Names: Soltamox

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₉NO

CAS Number: 10540-29-1

Unique Ingredient Identifier: 094ZI81Y45

Background: Tamoxifen is a non-steroidal antiestrogen used to treat estrogen receptor positive breast cancers as well as prevent the incidence of breast cancer in high risk populations. Tamoxifen is used alone or as an adjuvant in these treatments. Tamoxifen may no longer be the preferred treatment for these types of cancers as patients generally have better survival, side effect profiles, and compliance with anastrozole.

Tamoxifen was granted FDA approval on 30 December 1977.

Indication: Tamoxifen is indicated to treat estrogen receptor positive metastatic breast cancer in adults, as an adjuvant in the treatment of early stage estrogen receptor positive breast cancer in adults, to reduce the risk of invasive breast cancer after surgery and radiation in adult women with ductal carcinoma in situ.

Associated Conditions: Breast Cancer, Contralateral Breast Cancer, Desmoid Tumor, Early Stage Estrogen Receptor (ER) Positive Breast Cancer, Gynecomastia, Invasive Breast Cancer, Ovarian Cancer, Puberty, Precocious, Metastatic Estrogen Receptor Positive Breast Cancer

Associated Therapies: Ovulation induction therapy

Clinical Trials

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

Phase 2

Not yet recruiting

Conditions: Anatomic Stage IV Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Locally Advanced Unresectable Triple-Negative Breast Carcinoma
Metastatic Triple-Negative Breast Carcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: Magnetic Resonance Imaging
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
Drug: Tamoxifen

First Posted Date: 2024-05-30

Last Posted Date: 2025-03-21

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 31

Registration Number: NCT06434064

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

External Mastalgia-oil Versus Oral Tamoxifen in Premenopausal Women with Severe Mastalgia

Phase 3

Not yet recruiting

Conditions: Mastalgia

Interventions: Drug: mastalgia-oil, tamoxifen placebo
Drug: mastalgia-oil placebo, tamoxifen

First Posted Date: 2024-05-08

Last Posted Date: 2024-11-28

Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Target Recruit Count: 456

Registration Number: NCT06404775

Locations: 🇨🇳
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

Low Dose Exemestane Vs Low Dose Tamoxifen in Post-menopausal Women At High Risk for Breast Cancer.

Phase 2

Not yet recruiting

Conditions: Breast Cancer

Interventions: Drug: Exemestane 25 MG
Drug: Tamoxifen 10 MG

First Posted Date: 2024-04-15

Last Posted Date: 2025-02-19

Lead Sponsor: Andrea DeCensi

Target Recruit Count: 140

Registration Number: NCT06364267

Locations: 🇮🇹
E.O. Ospedali Galliera, Genova, Italy

Maintenance Hormonal Therapy and DLBCL

Phase 2

Not yet recruiting

Conditions: Diffuse Large B Cell Lymphoma

Interventions: Drug: Tamoxifen 20mg

First Posted Date: 2024-04-09

Last Posted Date: 2024-04-09

Lead Sponsor: Sohag University

Target Recruit Count: 100

Registration Number: NCT06355401

Breast Cancer & Antiestrogenic Therapy & Brain

Not yet recruiting

Conditions: Breast Cancer Female
Healthy Female
Menopause
Anti-estrogenic Therapy

Interventions: Drug: Tamoxifen
Drug: Letrozole
Drug: Letrozole + GnRH

First Posted Date: 2024-04-04

Last Posted Date: 2024-04-04

Lead Sponsor: International Research Training Group 2804

Target Recruit Count: 180

Registration Number: NCT06346457

Locations: 🇩🇪
University of Tuebingen; Department of Psychiatry & Psychotherapy Tuebingen, Tuebingen, BW, Germany

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

Phase 2

Not yet recruiting

Conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
HER2-positive Breast Cancer
Breast Cancer

Interventions: Drug: Trastuzumab emtansine
Drug: Pertuzumab Injection
Drug: Docetaxel
Drug: Tamoxifen
Drug: Letrozole
Drug: Goserelin

First Posted Date: 2024-04-04

Last Posted Date: 2025-05-06

Lead Sponsor: University of Chicago

Target Recruit Count: 74

Registration Number: NCT06348134

Locations: 🇳🇬
Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC), Ile-Ife, Osun, Nigeria
🇺🇸
University of Chicago, Chicago, Illinois, United States

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

Phase 1

Recruiting

Conditions: Pancreatic Cyst
Pancreatic Mucinous Cystic Neoplasm

Interventions: Drug: Tamoxifen 20mg

First Posted Date: 2024-03-20

Last Posted Date: 2025-03-17

Lead Sponsor: University of Nebraska

Target Recruit Count: 15

Registration Number: NCT06320990

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

Phase 3

Not yet recruiting

Conditions: Breast Cancer

Interventions: Drug: Letrozole
Drug: Tamoxifen
Drug: Anastrozole
Drug: Exemestane

First Posted Date: 2024-01-25

Last Posted Date: 2025-04-20

Lead Sponsor: Region Örebro County

Target Recruit Count: 3832

Registration Number: NCT06223698

Locations: 🇸🇪
Visby Hospital, Visby, Gotland, Sweden
🇸🇪
Gävle Hospital, Gävle, Sweden
🇸🇪
Kalmar Hospital, Kalmar, Sweden

and more 12 locations

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

Phase 2

Recruiting

Conditions: Breast Atypical Hyperplasia
Breast Carcinoma
Breast Ductal Carcinoma In Situ
Breast Lobular Carcinoma In Situ

Interventions: Procedure: Biospecimen Collection
Procedure: Mammography
Other: Questionnaire Administration
Drug: Omega-3-Acid Ethyl Esters
Procedure: Random Periareolar Fine-Needle Aspiration
Drug: Tamoxifen

First Posted Date: 2024-01-08

Last Posted Date: 2025-05-13

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 66

Registration Number: NCT06195306

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
University of Kansas Cancer Center, Kansas City, Kansas, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial

Phase 2

Recruiting

Conditions: Breast Carcinoma
Breast Ductal Carcinoma In Situ
Breast Lobular Carcinoma In Situ
Estrogen Receptor-Positive Breast Carcinoma

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Mammography
Other: Questionnaire Administration
Drug: Tamoxifen

First Posted Date: 2023-12-28

Last Posted Date: 2025-05-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 200

Registration Number: NCT06184750

Locations: 🇺🇸
University of Arizona Cancer Center - Prevention Research Clinic, Tucson, Arizona, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
University of Illinois College of Medicine - Chicago, Chicago, Illinois, United States

and more 8 locations

Drug Development Updates

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