MedPath

Afimoxifene

Generic Name
Afimoxifene
Drug Type
Small Molecule
Chemical Formula
C26H29NO2
CAS Number
68392-35-8
Unique Ingredient Identifier
95K54647BZ
Background

Afimoxifene (4-Hydroxytamoxifen, trade name TamoGel) is a new estrogen inhibitor under investigation for a variety of estrogen-dependent conditions, including cyclic breast pain and gynecomastia. TamoGel is formulated using Enhanced Hydroalcoholic Gel (EHG) Technology. This technology enables percutaneous delivery of drugs that cannot be delivered orally. It is being developed by Ascent Therapeutics.

Indication

For the potential treatment of menstrual-cycle related mastalgia, fibrocystic breast disease, breast disease, gynecomastia and Keloid scarring.

Topical Afimoxifene in Treating Patients With Breast Cancer Who Have Undergone Radiation Therapy on One Breast

Phase 2
Recruiting
Conditions
Ductal Breast Carcinoma In Situ
Invasive Breast Carcinoma
Cancer Survivor
Interventions
Procedure: Core Biopsy
Other: Questionnaire Administration
First Posted Date
2019-07-05
Last Posted Date
2023-07-13
Lead Sponsor
Northwestern University
Target Recruit Count
156
Registration Number
NCT04009044
Locations
🇺🇸

University of Illinois Cancer Center, Chicago, Illinois, United States

🇺🇸

Northwestern University, Chicago, Illinois, United States

Afimoxifene in Reducing the Risk of Breast Cancer in Women With Mammographically Dense Breast

Phase 2
Completed
Conditions
Mammographically Dense Breast
Interventions
Other: Laboratory Biomarker Analysis
Other: Placebo
Other: Questionnaire Administration
First Posted Date
2017-02-24
Last Posted Date
2024-02-22
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
194
Registration Number
NCT03063619
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 2 locations

Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast

Phase 2
Completed
Conditions
Estrogen Receptor Positive
Ductal Breast Carcinoma In Situ
Interventions
Other: Laboratory Biomarker Analysis
Other: Placebo
First Posted Date
2016-12-15
Last Posted Date
2024-12-18
Lead Sponsor
Northwestern University
Target Recruit Count
100
Registration Number
NCT02993159
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

Saint Elizabeth Medical Center South, Edgewood, Kentucky, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

and more 3 locations

4-Hydroxytamoxifen or Tamoxifen Citrate in Treating Women With Newly Diagnosed Ductal Breast Carcinoma in Situ

Phase 2
Completed
Conditions
Ductal Breast Carcinoma in Situ
Estrogen Receptor-positive Breast Cancer
Interventions
Drug: oral placebo
Drug: placebo gel
First Posted Date
2009-08-06
Last Posted Date
2015-07-21
Lead Sponsor
Northwestern University
Target Recruit Count
27
Registration Number
NCT00952731
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women

Phase 2
Completed
Conditions
Cyclic Breast Pain, Cyclic Mastalgia
First Posted Date
2006-01-09
Last Posted Date
2023-08-16
Lead Sponsor
ASCEND Therapeutics
Target Recruit Count
146
Registration Number
NCT00272714

Effect of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women

Not Applicable
Completed
Conditions
Breast Cancer
First Posted Date
2004-06-11
Last Posted Date
2012-05-30
Lead Sponsor
Northwestern University
Registration Number
NCT00084344
Locations
🇺🇸

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

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