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Selective Estrogen Receptor Modulator

Afimoxifene for Mammographically Dense Breast

Phase 2
Waitlist Available
Led By Banu Arun, MD
Research Sponsored by M.D. Anderson Cancer Center
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 baseline to month 12
Awards & highlights

Study Summary

This trial looks at how well a drug called afimoxifene reduces the risk of breast cancer in women with dense breasts. The drug works by blocking the effects of estrogen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mammographic Breast Density Using Cumulus Software
Secondary outcome measures
4-OHT Plasma Levels
4-OHT Tissue Levels
Mammographic Breast Density Using Volpara Software

Side effects data

From 2021 Phase 2 trial • 194 Patients • NCT03063619
17%
General disorders and administration site conditions - Other, specify
17%
Hot flashes
14%
Headache
10%
Skin and subcutaneous tissue disorders - Other, specify
9%
Breast Pain
8%
Weight gain
6%
Fatigue
6%
Sinusitis
5%
Insomnia
5%
Diarrhea
5%
Upper respiratory infection
5%
Allergic rhinitis
4%
Nausea
4%
Rash maculo-papular
4%
Weight loss
4%
Pain
4%
Hypertension
4%
Pain in extremity
3%
Pruritus
3%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
3%
Tooth Infection
3%
Vomiting
3%
Cough
3%
Abdominal Pain
3%
Bruising
3%
Dyspnea
3%
Fall
3%
Alopecia
3%
Appendicitis
3%
Bronchial infection
3%
Edema limbs
3%
Flu-like symptoms
3%
Nasal congestion
3%
Dyspepsia
3%
Vascular disorders - Other, specify
3%
Myalgia
3%
Stomach pain
3%
Surgical and medical procedures - Other, specify
3%
Irregular menstruation
3%
Anxiety
1%
Musculoskeletal and connective tissue disorder - Other, specify
1%
Osteoporosis
1%
Cataract
1%
Conjunctivitis
1%
Blurred vision
1%
Dry Skin
1%
Presyncope
1%
Alanine aminotransferase increased
1%
Arthralgia
1%
Bloating
1%
Cholesterol high
1%
Dizziness
1%
Pharyngitis
1%
Photosensitivity
1%
Urticaria
1%
Mucosal infection
1%
Paresthesia
1%
Psychiatric disorders - Other, specify
1%
Urinary tract infection
1%
Vaginal Dryness
1%
Allergic reaction
1%
Constipation
1%
Back Pain
1%
Gastroesophageal reflux disease
1%
Chills
1%
Ear and labyrinth disorders - Other, specify
1%
Aspartate aminotransferase increased
1%
Menorrhagia
1%
Olfactory nerve disorder
1%
Otitis media
1%
Uterine obstruction
1%
Acute Diverticulitis
1%
Bone pain
1%
Agitation
1%
Irritability
1%
Hyperhidrosis
1%
Reproductive system and breast disorders - Other, specify
1%
Injury, poisoning and procedural complications - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
4-OHT Gel

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm B (afimoxifene)Experimental Treatment3 Interventions
Patients apply afimoxifene gel topically to each breast QD for up to 52 weeks.
Group II: Arm A (placebo)Placebo Group3 Interventions
Patients apply placebo gel topically to each breast QD for up to 52 weeks.
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?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,158 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,913,970 Total Patients Enrolled
Banu Arun, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,068 Total Patients Enrolled

Media Library

Afimoxifene (Selective Estrogen Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03063619 — Phase 2
Mammographically Dense Breast Research Study Groups: Arm A (placebo), Arm B (afimoxifene)
Mammographically Dense Breast Clinical Trial 2023: Afimoxifene Highlights & Side Effects. Trial Name: NCT03063619 — Phase 2
Afimoxifene (Selective Estrogen Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03063619 — Phase 2

Frequently Asked Questions

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

Is it possible to join this clinical trial at this time?

"Unfortunately, this particular study has wrapped up recruitment. First appearing on May 1st, 2017 and last updated on August 12th, 2022, the trial is no longer looking for participants. However, there are currently 1 breast cancer trials and 3 Afimoxifene trials that are actively recruiting patients."

Answered by AI

How many people are being enrolled in this clinical trial?

"At the moment, this particular clinical trial is not seeking any new participants. The last update to this study was on August 12th, 20212 and it was originally posted on May 1st, 2017. There are currently one study for breast cancer and three studies involving Afimoxifene that are actively recruiting patients."

Answered by AI

Has Afimoxifene been cleared for use in the United States?

"While Phase 2 trials don't have the same data supporting efficacy, there is evidence that Afimoxifene is safe. For this reason, Power gave it a score of 2."

Answered by AI

Could I join this experiment if I meet the requirements?

"To be eligible for this study, patients must have breast cancer and fall in the age range of 40 to 69. At present, there are 152 people that meet these criteria enrolled in the trial."

Answered by AI

In how many different hospitals is this clinical trial being run today?

"The clinical trial is currently running at five locations: Dana-Farber Cancer Institute in Boston, Columbia University/Herbert Irving Cancer Center in New york, Northwestern University in Chicago, and other locations."

Answered by AI

Is Afimoxifene a common drug in medical research?

"Afimoxifene was first trialled in 2016 at Kantonsspital Aarau. Since then, it has undergone 18952 completed clinical trials. Currently, there are 3 ongoing Afimoxifene trials with a majority of them taking place in Boston, Massachusetts."

Answered by AI

Will elderly patients be rejected from this experiment?

"The age limit for patients hoping to enroll in this study is 69 years old. The minimum age requirement is 40 years old."

Answered by AI
~27 spots leftby Mar 2025