← Back to Search

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 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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,131 Total Patients Enrolled

39 Trials studying Breast Cancer

12,475 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,053 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

BHR Pharma, LLCIndustry Sponsor

4 Previous Clinical Trials

1,507 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are actively conducting this experiment?

"This clinical trial is accepting patients at Memorial Sloan-Kettering Cancer Center in New york, Mayo Clinic in Rochester, and Duke University Medical Centre in Durham. Moreover, 6 other sites are being considered for recruitment."

Answered by AI

What is the estimated recruitment capacity for this clinical trial?

"To reach the desired sample size, this clinical trial requires 100 eligible participants that fit within the predetermined inclusion criteria. Patients can register to take part in this study at Memorial Sloan-Kettering Cancer Center in New york or Mayo Clinic located in Rochester, Minnesota."

Answered by AI

Has the FDA authorized Afimoxifene for use?

"Afimoxifene has been assessed at a 2 on our safety scale, as the available evidence only supports its security and not yet its efficacy."

Answered by AI

Is it possible to register for this experiment presently?

"Clinicaltrials.gov outlines that this research is recruiting participants, with the initial post date of May 31st 2017 and a most recent update on December 17th 2020."

Answered by AI

For what common ailments is Afimoxifene typically prescribed?

"Malignant neoplasms are commonly treated with Afimoxifene, which is also suitable for the management of ovarian cancer, ovulation induction therapy, and high-risk situations."

Answered by AI

Are there any other investigations that have explored the effects of Afimoxifene?

"Afimoxifene was initially trialed in 1994 at Queen Mary University of London. To date, 18974 trials have been concluded and 69 are still ongoing with a large portion being conducted in New york City."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through the Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02993159.

All > Dcis