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

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

Phase 1

Completed

Conditions: Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Interventions: Drug: LEE011
Drug: Tamoxifen
Drug: Fulvestrant
Drug: Letrozole
Drug: goserelin

First Posted Date: 2015-01-07

Last Posted Date: 2023-06-08

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 88

Registration Number: NCT02333370

Locations: 🇸🇬
Novartis Investigative Site, Singapore, Singapore

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

Phase 2

Terminated

Conditions: Postmenopausal
Metastatic Breast Cancer

Interventions: Drug: Tamoxifen
Drug: Ralimetinib (LY2228820 dimesylate)

First Posted Date: 2014-12-23

Last Posted Date: 2017-05-24

Lead Sponsor: Centre Francois Baclesse

Target Recruit Count: 8

Registration Number: NCT02322853

Locations: 🇫🇷
Centre Léon Bérard, Lyon, France
🇫🇷
Centre Jean Perrin, Clermont -Ferrand, France
🇫🇷
Centre Henri Becquerel, Rouen, France

and more 11 locations

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

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Everolimus
Drug: Exemestane
Drug: Tamoxifen
Drug: Fulvestrant
Drug: Anastrozole
Drug: Letrozole
Drug: Toremifine

First Posted Date: 2014-11-17

Last Posted Date: 2020-02-17

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 48

Registration Number: NCT02291913

Locations: 🇺🇸
Woodlands Medical Specialists, Pensacola, Florida, United States
🇺🇸
Hope Cancer Center, Terre Haute, Indiana, United States
🇺🇸
Center for Cancer and Blood Disorders, Fort Worth, Texas, United States

and more 5 locations

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

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: GDC-0032
Drug: Tamoxifen

First Posted Date: 2014-11-06

Last Posted Date: 2022-10-12

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 189

Registration Number: NCT02285179

Locations: 🇳🇱
Reinier de Graaf Gasthuis, Delft, Netherlands
🇳🇱
Haaglanden Medisch Centrum, Den Haag, Netherlands
🇫🇷
Gustave Roussy, Paris, France

and more 11 locations

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

Phase 3

Completed

Conditions: Advanced Metastatic Breast Cancer

Interventions: Drug: Tamoxifen
Drug: Ribociclib
Drug: Letrozole
Drug: Anastrozole
Drug: Goserelin
Drug: Placebo

First Posted Date: 2014-10-29

Last Posted Date: 2024-03-12

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 672

Registration Number: NCT02278120

Locations: 🇺🇸
Penn State University Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
🇺🇸
Danbury Hospital SC, Danbury, Connecticut, United States
🇺🇸
University Of California Los Angeles Dept of Onc, Los Angeles, California, United States

and more 33 locations

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer

Phase 2

Active, not recruiting

Conditions: Advanced, Persistent, or Recurrent Endometrial Cancer

Interventions: Drug: Tamoxifen
Drug: Everolimus
Drug: Letrozole
Drug: Medroxyprogesterone Acetate

First Posted Date: 2014-08-29

Last Posted Date: 2024-01-03

Lead Sponsor: GOG Foundation

Target Recruit Count: 74

Registration Number: NCT02228681

Locations: 🇺🇸
Magee Women's Hospital of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸
University of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
🇺🇸
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States

and more 23 locations

Endocrine Response in Women With Invasive Lobular Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Anastrozole
Drug: Tamoxifen
Drug: Fulvestrant

First Posted Date: 2014-08-01

Last Posted Date: 2024-08-22

Lead Sponsor: Priscilla McAuliffe

Target Recruit Count: 201

Registration Number: NCT02206984

Locations: 🇺🇸
Univ. of Washington, Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸
ALBERT EINSTEIN COLLEGE OF MEDICINE Montefiore Medical Center, Bronx, New York, United States
🇺🇸
Josh Plassmeyer, Pittsburgh, Pennsylvania, United States

and more 9 locations