Afimoxifene for No change needed.

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

Approved for 10 Other Conditions

Summary

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

Eligible Conditions

No change needed.
Ductal Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 month after surgery

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

+5 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

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