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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%
Hot flashes
17%
General disorders and administration site conditions - Other, specify
14%
Headache
10%
Skin and subcutaneous tissue disorders - Other, specify
9%
Breast Pain
8%
Weight gain
6%
Sinusitis
6%
Fatigue
5%
Diarrhea
5%
Insomnia
5%
Upper respiratory infection
5%
Allergic rhinitis
4%
Pain in extremity
4%
Pain
4%
Weight loss
4%
Hypertension
4%
Nausea
4%
Rash maculo-papular
3%
Bruising
3%
Myalgia
3%
Pruritus
3%
Vomiting
3%
Appendicitis
3%
Bronchial infection
3%
Dyspepsia
3%
Abdominal Pain
3%
Alopecia
3%
Anxiety
3%
Cough
3%
Dyspnea
3%
Edema limbs
3%
Fall
3%
Flu-like symptoms
3%
Irregular menstruation
3%
Nasal congestion
3%
Stomach pain
3%
Tooth Infection
3%
Vascular disorders - Other, specify
3%
Surgical and medical procedures - Other, specify
3%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
1%
Musculoskeletal and connective tissue disorder - Other, specify
1%
Conjunctivitis
1%
Otitis media
1%
Blurred vision
1%
Hyperhidrosis
1%
Gastroesophageal reflux disease
1%
Uterine obstruction
1%
Cataract
1%
Chills
1%
Psychiatric disorders - Other, specify
1%
Aspartate aminotransferase increased
1%
Bloating
1%
Acute Diverticulitis
1%
Agitation
1%
Allergic reaction
1%
Alanine aminotransferase increased
1%
Arthralgia
1%
Back Pain
1%
Cholesterol high
1%
Constipation
1%
Dizziness
1%
Dry Skin
1%
Irritability
1%
Menorrhagia
1%
Mucosal infection
1%
Olfactory nerve disorder
1%
Osteoporosis
1%
Paresthesia
1%
Pharyngitis
1%
Photosensitivity
1%
Presyncope
1%
Urinary tract infection
1%
Vaginal Dryness
1%
Reproductive system and breast disorders - Other, specify
1%
Urticaria
1%
Bone pain
1%
Injury, poisoning and procedural complications - Other, specify
1%
Ear and labyrinth disorders - 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
2,987 Previous Clinical Trials
1,797,820 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,169 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
~26 spots leftby Jun 2025
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