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

Adjuvant High-Dose, Sequential Chemotherapy in Treating Patients With Resected Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

First Posted Date: 2004-02-06

Last Posted Date: 2009-08-26

Lead Sponsor: Yale University

Target Recruit Count: 89

Registration Number: NCT00002679

Locations: 🇺🇸
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States

Trastuzumab and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

First Posted Date: 2004-02-03

Last Posted Date: 2011-03-28

Lead Sponsor: NYU Langone Health

Registration Number: NCT00009997

Locations: 🇺🇸
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States

Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast Cancer

Phase 3

Conditions: Breast Cancer

First Posted Date: 2004-01-23

Last Posted Date: 2013-12-19

Lead Sponsor: International Collaborative Cancer Group

Target Recruit Count: 4400

Registration Number: NCT00003418

Locations: 🇧🇪
U.Z. Gasthuisberg, Leuven, Belgium
🇫🇷
Centre Antoine Lacassagne, Nice, France
🇬🇧
Charing Cross Hospital, London, England, United Kingdom

Combination Chemotherapy in Treating Women With Breast Cancer

Phase 3

Conditions: Breast Cancer

First Posted Date: 2003-12-05

Last Posted Date: 2013-11-06

Lead Sponsor: Scottish Cancer Therapy Network

Target Recruit Count: 350

Registration Number: NCT00003679

Locations: 🇬🇧
C.R.C. Beatson Laboratories, Glasgow, Scotland, United Kingdom

Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: tamoxifen citrate
Drug: Anastrozole

First Posted Date: 2003-11-06

Last Posted Date: 2021-10-06

Lead Sponsor: Queen Mary University of London

Target Recruit Count: 2980

Registration Number: NCT00072462

Locations: 🇮🇪
Mid-Western Regional Hospital, Limerick, Ireland
🇬🇧
Nottingham City Hospital, Nottingham, England, United Kingdom
🇬🇧
Centre for Cancer Research and Cell Biology at Queen's University Belfast, Belfast, Northern Ireland, United Kingdom

and more 94 locations

Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

Phase 2

Completed

Conditions: Desmoid Tumor

Interventions: Drug: tamoxifen citrate
Drug: sulindac
Other: laboratory biomarker analysis

First Posted Date: 2003-09-11

Last Posted Date: 2020-02-19

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 70

Registration Number: NCT00068419

Locations: 🇺🇸
Children's Oncology Group, Monrovia, California, United States

Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer

Phase 3

Terminated

Conditions: Endometrial Cancer

First Posted Date: 2003-09-09

Last Posted Date: 2013-04-11

Lead Sponsor: Gynecologic Oncology Group

Registration Number: NCT00016341

Locations: 🇺🇸
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
🇺🇸
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
🇺🇸
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States

and more 47 locations

Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer

Phase 3

Terminated

Conditions: Cardiac Toxicity
Inflammatory Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IV Breast Cancer

Interventions: Drug: dexrazoxane hydrochloride
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: paclitaxel
Biological: trastuzumab
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Drug: tamoxifen citrate
Other: laboratory biomarker analysis

First Posted Date: 2003-09-04

Last Posted Date: 2013-01-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 396

Registration Number: NCT00016276

Locations: 🇺🇸
Cancer and Leukemia Group B, Chicago, Illinois, United States

Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

First Posted Date: 2003-08-29

Last Posted Date: 2017-01-13

Lead Sponsor: University of Kansas Medical Center

Registration Number: NCT00005886

Locations: 🇺🇸
Comprehensive Cancer Centers of the Desert, Palm Springs, California, United States
🇺🇸
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
🇺🇸
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States

and more 6 locations

Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes

Phase 3

Completed

Conditions: Breast Cancer

First Posted Date: 2003-08-25

Last Posted Date: 2023-06-15

Lead Sponsor: Eastern Cooperative Oncology Group

Registration Number: NCT00004125

Locations: 🇺🇸
State University of New York - Upstate Medical University, Syracuse, New York, United States
🇺🇸
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States
🇺🇸
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

and more 45 locations

Drug Development Updates

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