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

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

Phase 2

Recruiting

Conditions: Locally Advanced Unresectable HER2-Negative Breast Carcinoma
Metastatic HER2-Negative Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma
Metastatic Hormone Receptor-Positive Breast Carcinoma

Interventions: Drug: Abemaciclib
Drug: Anastrozole
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Diagnostic Imaging
Drug: Exemestane
Other: Fludeoxyglucose F-18
Drug: Fluorine F 18 Fluoro Furanyl Norprogesterone
Drug: Fulvestrant
Biological: Gonadotropin-releasing Hormone Analog
Drug: Letrozole
Procedure: Positron Emission Tomography
Drug: Tamoxifen
Drug: Therapeutic Estradiol

First Posted Date: 2023-12-21

Last Posted Date: 2025-03-12

Lead Sponsor: University of Washington

Target Recruit Count: 60

Registration Number: NCT06179303

Locations: 🇺🇸
Siteman Cancer Center at Washington University, Saint Louis, Missouri, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)

Phase 2

Recruiting

Conditions: Systemic Lupus Erythematosus

Interventions: Biological: MK-6194
Biological: Placebo

First Posted Date: 2023-12-07

Last Posted Date: 2025-05-15

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 270

Registration Number: NCT06161116

Locations: 🇺🇸
Medvin Clinical Research - Metyas ( Site 0128), Covina, California, United States
🇺🇸
IRIS Research and Development, LLC-Research ( Site 0117), Plantation, Florida, United States
🇺🇸
Clinical Research of West Florida, Inc ( Site 0124), Tampa, Florida, United States

and more 121 locations

A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)

Phase 2

Active, not recruiting

Conditions: Non-segmental Vitiligo

Interventions: Biological: MK-6194
Drug: Placebo

First Posted Date: 2023-11-02

Last Posted Date: 2025-04-02

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 169

Registration Number: NCT06113328

Locations: 🇺🇸
The Vitiligo & Pigmentation Institute of Southern California ( Site 0115), Los Angeles, California, United States
🇹🇷
Ankara Bilkent Şehir Hastanesi-Dermatology ( Site 1502), Ankara, Turkey
🇺🇸
Cahaba Dermatology & Skin Health Center ( Site 0127), Birmingham, Alabama, United States

and more 65 locations

DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment

Phase 2

Recruiting

Conditions: Ductal Carcinoma in Situ

Interventions: Drug: Testosterone + Anastrazole
Drug: Z-endoxifen
Drug: Tamoxifen
Drug: Elacestrant
Drug: Exemestane
Drug: Letrozole
Drug: Anastrazole

First Posted Date: 2023-10-10

Last Posted Date: 2025-04-29

Lead Sponsor: QuantumLeap Healthcare Collaborative

Target Recruit Count: 400

Registration Number: NCT06075953

Locations: 🇺🇸
Berkeley Outpatient Center, Berkeley, California, United States
🇺🇸
UCSF, San Francisco, California, United States
🇺🇸
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

and more 5 locations

Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion

Phase 2

Recruiting

Conditions: RAD51C Gene Mutation
PALB2 Gene Mutation
Ductal Carcinoma in Situ
Lobular Carcinoma in Situ
RAD51D Gene Mutation
CDH1 Gene Mutation
BRCA Mutation
ATM Gene Mutation
CHEK2 Gene Mutation

Interventions: Drug: Tamoxifen 10 mg Tablet
Behavioral: Step counter Device
Other: Intermittent caloric restriction

First Posted Date: 2023-09-13

Last Posted Date: 2024-07-01

Lead Sponsor: European Institute of Oncology

Target Recruit Count: 200

Registration Number: NCT06033092

Locations: 🇮🇹
E.O. Galliera, Genoa, Italy
🇮🇹
Istituto Europeo di Oncologia, Milan, Italy
🇮🇹
Istituto Nazionale Tumori G. Pascale, Napoli, Italy

and more 1 locations

TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer

Phase 2

Active, not recruiting

Conditions: Early-stage Breast Cancer
Breast Cancer
High Risk Breast Carcinoma

Interventions: Drug: Abemaciclib
Drug: Tamoxifen
Drug: Anastrozole
Drug: Letrozole
Drug: Exemestane
Drug: LHRH Agonist

First Posted Date: 2023-08-21

Last Posted Date: 2024-11-07

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 90

Registration Number: NCT06001762

Locations: 🇺🇸
Stamford Hospital, Stamford, Connecticut, United States
🇺🇸
Eastern Maine Medical Center (Northern Light), Brewer, Maine, United States
🇺🇸
New England Cancer Specialists, Scarborough, Maine, United States

and more 9 locations

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Phase 3

Recruiting

Conditions: Breast Cancer, Early Breast Cancer

Interventions: Drug: Tamoxifen
Drug: Camizestrant
Drug: Anastrozole
Drug: Abemaciclib
Drug: Letrozole
Drug: Exemestane

First Posted Date: 2023-07-19

Last Posted Date: 2025-05-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 5500

Registration Number: NCT05952557

Locations: 🇬🇧
Research Site, Whitchurch, United Kingdom

Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer

Phase 2

Recruiting

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

Interventions: Drug: Acolbifene Hydrochloride
Procedure: Biospecimen Collection
Procedure: Mammography
Other: Questionnaire Administration
Procedure: Random Periareolar Fine-Needle Aspiration
Drug: Tamoxifen

First Posted Date: 2023-07-12

Last Posted Date: 2025-05-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 80

Registration Number: NCT05941520

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
University of Kansas Cancer Center, Kansas City, Kansas, United States

and more 1 locations

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

Phase 3

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Fluzoparib
Drug: Anastrozole
Drug: Letrozole
Drug: Exemestane
Drug: Tamoxifen
Drug: Toremifene
Drug: Abemaciclib
Drug: LHRH agonist

First Posted Date: 2023-06-06

Last Posted Date: 2024-02-08

Lead Sponsor: Fudan University

Target Recruit Count: 766

Registration Number: NCT05891093

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangdong, Guangzhou, China
🇨🇳
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai, Shanghai, China
🇨🇳
Fujian Medical University Union Hospital, Fuzhou, Fujian, China

and more 12 locations

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

Not yet recruiting

Conditions: Hormone-receptor-positive Breast Cancer
Premenopausal Breast Cancer
Breast Cancer Patients at Intermediate to High Risk
Ovarian Function Suppression Combined With Aromatase Inhibitor or Tamoxifen or Torimefen

Interventions: Procedure: ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist)
Drug: Aromatase inhibitor
Drug: Tamoxifen
Drug: toremifene

First Posted Date: 2023-04-06

Last Posted Date: 2023-05-18

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

Target Recruit Count: 700

Registration Number: NCT05801705

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

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