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

Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02

Phase 3

Completed

Conditions: Fatigue
Breast Cancer
Sleep Disorders

Interventions: Drug: Tamoxifen
Drug: triptorelin
Drug: Exemestane

First Posted Date: 2008-04-16

Last Posted Date: 2016-07-25

Lead Sponsor: ETOP IBCSG Partners Foundation

Target Recruit Count: 86

Registration Number: NCT00659373

Locations: 🇺🇸
Front Range Cancer Specialists, Fort Collins, Colorado, United States
🇺🇸
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care, Concord, New Hampshire, United States
🇺🇸
Batte Cancer Center at Northeast Medical Center, Concord, North Carolina, United States

and more 12 locations

Casodex - Nolvadex Combination

Phase 2

Completed

Conditions: Gynaecomastia
Prostate Cancer

Interventions: Drug: Casodex
Drug: Tamoxifen

First Posted Date: 2008-03-18

Last Posted Date: 2011-01-24

Lead Sponsor: AstraZeneca

Registration Number: NCT00637871

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

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Tamoxifen
Drug: Anastrazole (Arimidex)
Drug: Goserelin acetate (Zoladex)

First Posted Date: 2008-01-31

Last Posted Date: 2012-09-06

Lead Sponsor: AstraZeneca

Target Recruit Count: 197

Registration Number: NCT00605267

Locations: 🇯🇵
Research Site, Osaka, Japan

Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer

Phase 3

Active, not recruiting

Conditions: Stage III Breast Cancer AJCC v6
Recurrent Breast Carcinoma
Stage IV Breast Cancer AJCC v6 and v7
Invasive Breast Carcinoma

Interventions: Biological: Bevacizumab
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Questionnaire Administration
Drug: Tamoxifen Citrate

First Posted Date: 2008-01-28

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 394

Registration Number: NCT00601900

Locations: 🇺🇸
Northside Hospital, Atlanta, Georgia, United States
🇺🇸
Augusta University Medical Center, Augusta, Georgia, United States
🇺🇸
WellStar Cobb Hospital, Austell, Georgia, United States

and more 517 locations

Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394)

Phase 3

Completed

Conditions: Breast Cancer
Cyclophosphamide
High Risk
Doxorubicin
Positive Nodes

Interventions: Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: G-CSF
Drug: tamoxifen
Drug: ciprofloxacin

First Posted Date: 2008-01-11

Last Posted Date: 2017-08-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 60

Registration Number: NCT00590785

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Post Operative Adjuvant Chemotherapy Followed by Adjuvant Tamoxifen vs Nil for Patients With Operable Breast Cancer

Not Applicable

Conditions: Breast Cancer

First Posted Date: 2007-10-02

Last Posted Date: 2011-12-13

Lead Sponsor: King Faisal Specialist Hospital & Research Center

Target Recruit Count: 2000

Registration Number: NCT00538330

Liver Safety Under Upfront Arimidex vs Tamoxifen

Phase 4

Completed

Conditions: Breast Cancer

Interventions: Drug: Anastrozole
Drug: Tamoxifen

First Posted Date: 2007-10-01

Last Posted Date: 2013-01-25

Lead Sponsor: AstraZeneca

Target Recruit Count: 384

Registration Number: NCT00537771

Locations: 🇨🇳
Research Site, Tianjin, China

Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen

Phase 2

Terminated

Conditions: Breast Cancer
Metastatic Disease

Interventions: Drug: Tamoxifen

First Posted Date: 2007-09-20

Last Posted Date: 2010-02-10

Lead Sponsor: National Cancer Center, Korea

Target Recruit Count: 21

Registration Number: NCT00532454

Locations: 🇰🇷
National Cancer Center, 809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of
🇰🇷
National cancer center, Goyang-si, Gyeonggi-do, Korea, Republic of