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

Long-term Follow-up of the TAM-01 Study, a Phase III Trial of Low Dose Tamoxifen in Breast DCIS and Premalignant Disease

Not yet recruiting

Conditions: Breast Cancer Invasive

Interventions: Drug: Tamoxifen (Nolvadex)
Drug: Tamoxifen (Nolvadex) placebo

First Posted Date: 2025-05-21

Last Posted Date: 2025-05-21

Lead Sponsor: Ente Ospedaliero Ospedali Galliera

Target Recruit Count: 500

Registration Number: NCT06982313

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

A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)

Phase 2

Not yet recruiting

Conditions: Malignant Neoplasm

Interventions: Drug: Megestrol acetate/Medroxyprogesterone acetate
Drug: MK-5684
Drug: Fulvestrant
Drug: Tamoxifen
Drug: Fludrocortisone/ Fludrocortisone acetate
Drug: Exemestane
Drug: Letrozole
Drug: Dexamethasone/Dexamethasone acetate
Drug: Rescue Medications

First Posted Date: 2025-05-20

Last Posted Date: 2025-05-20

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 250

Registration Number: NCT06979596

Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation

Early Phase 1

Not yet recruiting

Conditions: CNS Embryonal Tumor
CNS, Medulloblastoma
Atypical Teratoid Rhabdoid Tumor
Medulloblastoma, Childhood
Medulloblastoma, Group 3
Medulloblastoma, Group 4
Pineoblastoma
Embryonal Tumor With Abundant Neuropil and True Rosettes
Ependymoblastoma
Medulloepithelioma

Interventions: Drug: Cytarabine IT
Drug: hydrocortisone
Drug: Cisplatin
Drug: Vincristine
Drug: Etoposide
Drug: Cyclophosphamide
Drug: Mesna
Drug: Filgrastim
Drug: carboplatin
Drug: Thiotepa
Drug: Topotecan IT
Drug: Tamoxifen
Drug: ISOtretinoin
Drug: Celecoxib
Drug: etoposide phosphate
Drug: Temozolomide

First Posted Date: 2025-04-24

Last Posted Date: 2025-04-24

Lead Sponsor: C17 Council

Target Recruit Count: 15

Registration Number: NCT06942039

Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

Phase 2

Recruiting

Conditions: Pancreatic Neoplasms

Interventions: Drug: Tamoxifen 20 mg

First Posted Date: 2025-04-06

Last Posted Date: 2025-04-06

Lead Sponsor: Fudan University

Target Recruit Count: 30

Registration Number: NCT06914674

Locations: 🇨🇳
Shanghai Cancer Center, Shanghai, China

A Single Dose Study of MK-6194 in Healthy Chinese Participants (MK-6194-014)

Phase 1

Completed

Conditions: Healthy

Interventions: Biological: MK-6194
Biological: Placebo

First Posted Date: 2025-02-12

Last Posted Date: 2025-02-12

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 37

Registration Number: NCT06821334

Locations: 🇨🇳
Peking University Third Hospital (Site 0001), Beijing, Beijing, China

Testing Low Dose Tamoxifen for Invasive Breast Cancer, the (LoTam) Trial

Phase 3

Recruiting

Conditions: Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage 1 Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Estrogen Receptor-Positive Breast Carcinoma
HER2-Negative Breast Carcinoma

Interventions: Drug: Tamoxifen
Drug: Anastrozole
Procedure: Mammogram
Drug: Letrozole
Drug: Exemestane
Procedure: Magnetic Resonance Imaging
Biological: Dual X-ray Absorptiometry
Procedure: Biospecimen Collection
Other: Questionnaire Administration

First Posted Date: 2024-11-04

Last Posted Date: 2025-04-02

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 1156

Registration Number: NCT06671912

Locations: 🇺🇸
Bon Secours Saint Mary's Hospital, Richmond, Virginia, United States
🇺🇸
Keck Medicine of USC Buena Park, Buena Park, California, United States
🇺🇸
Enloe Medical Center, Chico, California, United States

and more 110 locations

MK-6194 Site of Injection Study in Healthy Adult Participants (MK-6194-013)

Phase 1

Completed

Conditions: Healthy

Interventions: Biological: MK-6194

First Posted Date: 2024-10-21

Last Posted Date: 2024-10-21

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 16

Registration Number: NCT06649877

Locations: 🇺🇸
QPS-MRA, LLC-Early Phase (Site 0001), South Miami, Florida, United States

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

Phase 2

Not yet recruiting

Conditions: Advanced Breast Carcinoma
Advanced Malignant Solid Neoplasm
Advanced Ovarian Carcinoma
Advanced Pancreatic Carcinoma
Advanced Prostate Carcinoma
Advanced Sarcoma
Anatomic Stage III Breast Cancer AJCC V8
Anatomic Stage IV Breast Cancer AJCC V8
Stage III Ovarian Cancer AJCC V8
Stage III Pancreatic Cancer AJCC V8

Interventions: Drug: Abemaciclib
Procedure: Biopsy
Procedure: Biospecimen Collection
Drug: Fulvestrant
Procedure: Bone Scan
Drug: Carboplatin
Drug: Olaparib
Procedure: Echocardiography
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Exemestane
Drug: Letrozole
Drug: Gefitinib
Procedure: Multigated Acquisition Scan
Other: Survey Administration
Drug: Tamoxifen
Drug: Temozolomide
Drug: Paclitaxel
Drug: Osimertinib
Drug: Pegylated Liposomal Doxorubicin Hydrochloride

First Posted Date: 2024-10-08

Last Posted Date: 2025-02-13

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 30

Registration Number: NCT06630325

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

Phase 3

Recruiting

Conditions: Breast Cancer

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

First Posted Date: 2024-07-09

Last Posted Date: 2025-05-21

Lead Sponsor: Stemline Therapeutics, Inc.

Target Recruit Count: 4220

Registration Number: NCT06492616

Locations: 🇪🇸
Hospital Beata Maria Ana, Madrid, Spain
🇺🇸
Southern Cancer Center, PC, Daphne, Alabama, United States
🇺🇸
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

and more 169 locations

A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy

Phase 3

Recruiting

Conditions: Hot Flashes

Interventions: Drug: Fezolinetant
Drug: Placebo
Drug: Tamoxifen
Drug: Aromatase inhibitor

First Posted Date: 2024-06-04

Last Posted Date: 2025-05-07

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 540

Registration Number: NCT06440967

Locations: 🇫🇷
Site FR33002, Saint Herblain Cedex, France
🇩🇪
Site DE49001, Bottrop, Germany
🇩🇪
Site DE49009, Leipzig, Germany

and more 63 locations

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