MedPath

Tamoxifen

Generic Name
Tamoxifen
Brand Names
Soltamox
Drug Type
Small Molecule
Chemical Formula
C26H29NO
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

Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Phase 3
Completed
Conditions
Primary Peritoneal Cavity Cancer
Stage III Ovarian Epithelial Cancer
Recurrent Ovarian Epithelial Cancer
Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Interventions
Drug: thalidomide
Drug: tamoxifen citrate
Other: laboratory biomarker analysis
First Posted Date
2003-01-27
Last Posted Date
2019-07-30
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
139
Registration Number
NCT00041080
Locations
🇺🇸

Gynecologic Oncology Group, Philadelphia, Pennsylvania, United States

A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) With/Without Tamoxifen in Patients With Osteosarcoma

Phase 1
Completed
Conditions
Neoplasm Metastasis
Osteosarcoma
First Posted Date
2002-12-10
Last Posted Date
2008-03-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
24
Registration Number
NCT00001436
Locations
🇺🇸

National Cancer Institute (NCI), Bethesda, Maryland, United States

Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer

Phase 3
Completed
Conditions
Breast Neoplasms
Interventions
First Posted Date
2002-06-03
Last Posted Date
2014-05-07
Lead Sponsor
Pfizer
Target Recruit Count
4740
Registration Number
NCT00038467
Locations
🇬🇧

Pfizer Investigational Site, Wythenshawe, Manchester, United Kingdom

Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.

Phase 3
Completed
Conditions
Breast Neoplasms
First Posted Date
2002-04-24
Last Posted Date
2006-07-19
Lead Sponsor
Eli Lilly and Company
Registration Number
NCT00034125

Examination of Tamoxifen in Acute Mania in Patients With Bipolar I Disorder

Phase 2
Completed
Conditions
Bipolar Disorder
First Posted Date
2001-11-12
Last Posted Date
2017-07-02
Lead Sponsor
National Institute of Mental Health (NIMH)
Target Recruit Count
50
Registration Number
NCT00026585
Locations
🇺🇸

Howard University Hospital, Washington, D.C., District of Columbia, United States

Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer

First Posted Date
2000-06-14
Last Posted Date
2013-03-19
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
30
Registration Number
NCT00005908
Locations
🇺🇸

National Naval Medical Center, Bethesda, Maryland, United States

Tamoxifen Study

Phase 3
Completed
Conditions
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Hypertension
Myocardial Ischemia
First Posted Date
1999-10-28
Last Posted Date
2016-11-02
Lead Sponsor
NSABP Foundation Inc
Registration Number
NCT00000529
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