NCT03063619

Afimoxifene in Reducing the Risk of Breast Cancer in Women With Mammographically Dense Breast

Completed Phase 2 Results posted Last updated 22 February 2024

What this trial tests

Phase 2 trial testing Afimoxifene in Mammographically Dense Breast in 194 participants. Completed in 26 October 2021.

Timeline

30 January 2018

Primary endpoint
26 October 2021

26 October 2021

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	194
Start date	30 January 2018
Primary completion	26 October 2021
Estimated completion	26 October 2021
Sites	5 locations across United States

Drugs / interventions tested

• Afimoxifene — full drug profile →
• Laboratory Biomarker Analysis — full drug profile →
• Placebo
• Questionnaire Administration

Conditions studied

• Mammographically Dense Breast — all drugs for Mammographically Dense Breast →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 40 to 69, female only, with Mammographically Dense Breast. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mammographic Breast Density Using Cumulus Software Primary · Baseline to Month 12

To determine change of mammographic breast density using Cumulus software. Cumulus is a semi-automated computerized measure of dense area that uses reader-based thresholds to define the breast edge and regions of density on a digital or digitized mammogram. Each pixel within the breast area between the skin line and pectoral muscle is segmented into either fat or fibro glandular tissue; this defines the cut-off point.

Craniocaudal View (CC view)

Group	Value	95% CI
4-OHT Gel	-6.30	± 9.11
Placebo	-5.77	± 11.24

Mediolateral Oblique View (MLO view)

Group	Value	95% CI
4-OHT Gel	-2.81	± 6.74
Placebo	-5.43	± 9.08

Mammographic Breast Density Using Volpara Software Secondary · Baseline to Month 12

To determine change of mammographic breast density using Volpara software. Volpara software uses a combination of x-ray physics and machine learning to generate an accurate volumetric measure of breast composition.

Craniocaudal View (CC view)

Group	Value	95% CI
4-OHT Gel	-1.31	± 1.87
Placebo	-0.85	± 2.35

Mediolateral Oblique View (MLO view)

Group	Value	95% CI
4-OHT Gel	-0.92	± 4.26
Placebo	-0.30	± 4.60

4-OHT Plasma Levels Secondary · Baseline to Month 12

To evaluate plasma measurements of 4-OHT levels, Z-4-OH-Tamoxifen.

Below Qualification Limit (BQL) at 12 months

Group	Value	95% CI
4-OHT Gel	42
Placebo	57

Greater than BQL at 12 months

Group	Value	95% CI
4-OHT Gel	17
Placebo	0

4-OHT Tissue Levels Secondary · Baseline to Month 12

To evaluate tissue measurements of 4-OHT levels, Z-4-OH-Tamoxifen

Below Qualification Limit (BQL)

Group	Value	95% CI
4-OHT Gel	2
Placebo	18

Greater than BQL

Group	Value	95% CI
4-OHT Gel	10
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Month 12. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

4-OHT Gel

Serious: 3/78 (4%)

Deaths: 0/78

Placebo

Serious: 5/80 (6%)

Deaths: 0/80

Serious adverse events (7 terms)

Reaction	System	4-OHT Gel	Placebo
Appendicitis	Infections and infestations	—	—
Acute Diverticulitis	Gastrointestinal disorders	—	—
Perianal Abscess	Infections and infestations	—	—
Hip Fracture	Injury, poisoning and procedural complications	—	—
Automobile Accident/Injury	Injury, poisoning and procedural complications	—	—
Right Breast IDC/Neoplasms	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Invasive Breast Cancer/Neoplasms	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (106 terms — click to expand)

Reaction	System	4-OHT Gel	Placebo
General disorders and administration site conditions - Other, specify	General disorders	—	—
Hot flashes	Vascular disorders	—	—
Headache	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	—	—
Breast Pain	Reproductive system and breast disorders	—	—
Weight gain	Investigations	—	—
Fatigue	General disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Sinusitis	Infections and infestations	—	—
Allergic reaction	Immune system disorders	—	—
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	—	—
Anxiety	Psychiatric disorders	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Insomnia	Psychiatric disorders	—	—
Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	—	—
Vaginal Dryness	Reproductive system and breast disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Dry Skin	Skin and subcutaneous tissue disorders	—	—
Hypertension	Vascular disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Pain	General disorders	—	—
Pain in extremity	General disorders	—	—
Paresthesia	Nervous system disorders	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—
Weight loss	Investigations	—	—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Reproductive system and breast disorders - Other, specify	Reproductive system and breast disorders	—	—
Abdominal Pain	Gastrointestinal disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Bloating	Gastrointestinal disorders	—	—
Bronchial infection	Infections and infestations	—	—
Bruising	Injury, poisoning and procedural complications	—	—
Cholesterol high	Investigations	—	—
Depression	Psychiatric disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Edema limbs	General disorders	—	—
Eye disorders - Other, specify	Eye disorders	—	—

Most-reported serious reactions: Appendicitis, Acute Diverticulitis, Perianal Abscess, Hip Fracture, Automobile Accident/Injury, Right Breast IDC/Neoplasms, Invasive Breast Cancer/Neoplasms.

Data from ClinicalTrials.gov NCT03063619 adverse events section.

Sponsor's own description

This randomized phase II trial studies how well afimoxifene works in reducing the risk of breast cancer in women with mammographically dense breast. Estrogen can cause the growth of breast cancer cells. Hormone therapy using afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.