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Selective Estrogen Receptor Modulator

Afimoxifene in Reducing the Risk of Breast Cancer in Women With 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

Summary

This trial studies how well afimoxifene gel reduces breast cancer risk in women with dense breast tissue by blocking 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mammographic Breast Density Using Cumulus Software
Secondary study objectives
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%
Sinusitis
6%
Fatigue
5%
Diarrhea
5%
Allergic rhinitis
5%
Insomnia
5%
Upper respiratory infection
4%
Pain
4%
Rash maculo-papular
4%
Nausea
4%
Pain in extremity
4%
Weight loss
4%
Hypertension
3%
Surgical and medical procedures - Other, specify
3%
Bruising
3%
Flu-like symptoms
3%
Pruritus
3%
Irregular menstruation
3%
Cough
3%
Vascular disorders - Other, specify
3%
Tooth Infection
3%
Nasal congestion
3%
Stomach pain
3%
Bronchial infection
3%
Myalgia
3%
Vomiting
3%
Abdominal Pain
3%
Appendicitis
3%
Alopecia
3%
Anxiety
3%
Dyspepsia
3%
Dyspnea
3%
Edema limbs
3%
Fall
3%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
1%
Olfactory nerve disorder
1%
Agitation
1%
Musculoskeletal and connective tissue disorder - Other, specify
1%
Conjunctivitis
1%
Irritability
1%
Constipation
1%
Pharyngitis
1%
Menorrhagia
1%
Psychiatric disorders - Other, specify
1%
Cholesterol high
1%
Bone pain
1%
Chills
1%
Urticaria
1%
Cataract
1%
Urinary tract infection
1%
Vaginal Dryness
1%
Dizziness
1%
Mucosal infection
1%
Osteoporosis
1%
Paresthesia
1%
Allergic reaction
1%
Uterine obstruction
1%
Alanine aminotransferase increased
1%
Presyncope
1%
Photosensitivity
1%
Acute Diverticulitis
1%
Arthralgia
1%
Aspartate aminotransferase increased
1%
Back Pain
1%
Bloating
1%
Blurred vision
1%
Dry Skin
1%
Ear and labyrinth disorders - Other, specify
1%
Gastroesophageal reflux disease
1%
Hyperhidrosis
1%
Otitis media
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
4-OHT Gel
Placebo

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
3,070 Previous Clinical Trials
1,802,614 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,994 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
~25 spots leftby Dec 2025
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