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Selective Estrogen Receptor Modulator

Afimoxifene for Breast Cancer

Phase 2
Recruiting
Led By Seema Khan, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month after surgery
Awards & highlights

Study Summary

This trial is testing two drugs to see how well they work in treating patients with estrogen-positive breast cancer.

Eligible Conditions
  • Ductal Breast Carcinoma In Situ
  • No change needed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ki67 labeling assessed by standard immunohistochemistry
Secondary outcome measures
CD68, p16, and COX2 assessed by IHC
Estradiol and progesterone levels in breast tissue and plasma assessed by liquid chromatography/tandem mass spectrometry
Fraction of subjects with "no residual DCIS" in surgical sample assessed by core needle biopsy
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (afimoxifene, placebo)Experimental Treatment3 Interventions
Patients apply afimoxifene gel to both breasts and receive placebo PO daily for 4-10 weeks in the absence of disease progression or unexpected toxicity.
Group II: Arm II (placebo, tamoxifen citrate)Active Control3 Interventions
Patients apply placebo gel to both breasts and receive tamoxifen citrate orally PO daily for 4-10 weeks in the absence of disease progression or unexpected toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Afimoxifene
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,602 Previous Clinical Trials
915,565 Total Patients Enrolled
39 Trials studying Breast Cancer
12,475 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,734 Previous Clinical Trials
40,967,504 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
BHR Pharma, LLCIndustry Sponsor
4 Previous Clinical Trials
1,507 Total Patients Enrolled
~12 spots leftby Jun 2025