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Selective Estrogen Receptor Modulator

Endoxifen for Breast Cancer

Phase 1

Waitlist Available

Led By Seema A Khan

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to understand and the willingness to sign a written informed consent document which includes a requirement to apply study agent to sensitive body parts daily

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 days

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of a drug called endoxifen hydrochloride in people who are having breast surgery. Endoxifen hydrochloride may help treat or prevent breast cancer.

Who is the study for?

This trial is for women over 18 with confirmed stage 0-III breast cancer or high risk of breast cancer, who are scheduled for mastectomy. They must have normal organ function and agree to use birth control. Excluded are those with recent breast cancer therapy, skin diseases, a history of blood clots or uterine cancer risks, current users of topical medications on the breasts (unless willing to stop), and pregnant or breastfeeding women.Check my eligibility

What is being tested?

The trial is testing Endoxifen Hydrochloride gel applied to the breast versus a placebo in patients awaiting surgery. The aim is to determine the best dose and side effects of this potential treatment that may reduce the risk or treat breast cancer.See study design

What are the potential side effects?

While specific side effects aren't listed here, similar treatments often cause skin irritation at the application site. There could also be systemic effects due to absorption such as hot flashes, mood swings, vaginal dryness or discharge which are common with estrogen-targeting drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can understand and am willing to sign consent to apply a study treatment daily.

Select...

I am mostly active and can care for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Dermal Toxicity on Breast Skin at the Application Site

Secondary outcome measures

Change in Plasma Estrogenic and Coagulation Parameters

Change in Pre-therapy and Post-therapy Symptoms Captured by BESS Questionnaire

Drug Concentration in Plasma

+1 more

Other outcome measures

Tissue biologic response

Side effects data

From 2013 Phase 1 trial • 89 Patients • NCT01393990

33%

Leukopenia

33%

Anaemia

33%

Lymphopenia

33%

Hypoxia

33%

Vomiting

33%

Chest discomfort

33%

Insomnia

33%

Neutropenia

33%

Nausea

33%

Chest pain

33%

Chills

33%

Decreased appetite

33%

Dizziness

33%

Cough

33%

Oropharyngeal pain

33%

Dry skin

33%

Pyrexia

33%

Stomatitis

33%

Palpitations

33%

Diarrhoea

33%

Dysphagia

33%

Tremor

33%

Respiratory tract congestion

33%

Bronchitis

33%

Fatigue

33%

Seasonal allergy

100%

80%

60%

40%

20%

Study treatment Arm

Part A: 160 mg LY2228820 Capsules

Part D: 200 mg LY2228820 Tablets

Part D: 300 mg LY2228820 Tablets

Part A: 160 mg LY2228820 Bridge

Part A: 200 mg LY2228820 Tablets

Part A: 120 mg LY2228820 Capsules

Part A: 300 mg LY2228820 Tablets

Part A: 90 mg LY2228820 Capsules

Part A: 420 mg LY2228820 Tablets

Part C: 300 mg LY2228820 Tablets

Part A: 200 mg LY2228820 Capsules

Part A: 65 mg LY2228820 Capsules

Part A: 10 mg LY2228820 Capsules

Part A: 20 mg LY2228820 Capsules

Part A: 160 mg LY2228820 Tablets

Part A: 40 mg LY2228820 Capsules

Part B: 420 mg LY2228820 Tablets

Part A: 560 mg LY2228820 Tablets

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort I (endoxifen hydrochloride)Experimental Treatment2 Interventions

Participants apply endoxifen hydrochloride gel to both breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery.

Group II: Cohort II (placebo)Placebo Group2 Interventions

Participants apply placebo to both breast skin and keep it untouched over at least 4 hours once daily for 21-28 days before breast surgery.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,121 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Seema A KhanPrincipal InvestigatorNorthwestern University

2 Previous Clinical Trials

270 Total Patients Enrolled

Frequently Asked Questions

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

Does Endoxifen Hydrochloride pose any health risks to users?

"Endoxifen Hydrochloride has not been extensively studied yet, so our team assigned it a score of 1 on the safety scale. This is because this medication is in Phase 1 trials with limited data supporting its efficacy and security."

Answered by AI

Are there any available openings for enrollees in this experiment?

"Based on clinicaltrials.gov, this particular study is currently not recruiting participants, having been last updated in March 2022 since its original posting in October 2018. However, there are an abundance of concurrent medical trials that require patients to partake right now - a total of 4609 at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery

2018. "Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03317405.