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Aromatase Inhibitor

Endoxifen for Breast Cancer (EVANGELINE Trial)

Phase 2

Recruiting

Led By Matthew P Goetz, MD

Research Sponsored by Atossa Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

ER+/HER2-: [ER] ≥ 67% or Allred Score 6-8) / HER2- (histologically confirmed) using American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines

Nottingham Grade 1 or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to 4 weeks, up to 12 weeks and up to end of treatment or up to 24 weeks

Awards & highlights

EVANGELINE Trial Summary

This trial is studying if (Z)-endoxifen can effectively treat premenopausal women with ER+/HER2- breast cancer without the need for monthly injections of goserelin.

Who is the study for?

This trial is for premenopausal women over 18 with early-stage ER+/HER2- breast cancer. Participants must not be pregnant, lactating, or planning pregnancy within a year and agree to non-hormonal contraception. They should have an ECOG Performance Status of 0 to 2 and no prior breast cancer treatment or other active cancers in the last two years.Check my eligibility

What is being tested?

(Z)-endoxifen, a drug that blocks estrogen from binding to cancer cells, is being tested against standard treatments exemestane and goserelin. The study has two parts: determining the proper dose of (Z)-endoxifen and comparing its effectiveness with standard treatments by measuring changes in a tumor marker after about four weeks.See study design

What are the potential side effects?

(Z)-endoxifen may cause side effects similar to other SERMs like hot flashes, joint pain, mood swings, blood clots, vision changes due to cataracts or retinopathy. Exemestane can lead to bone loss or fractures; goserelin might cause symptoms related to low estrogen levels such as vaginal dryness.

EVANGELINE Trial Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is ER positive and HER2 negative, meeting specific test scores.

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My breast cancer is low or intermediate grade.

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My breast cancer is at stage IIA or IIB.

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My breast cancer is at stage T2 or T3 and has spread to nearby lymph nodes.

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I am a premenopausal woman aged 18 or older.

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My breast cancer is ER positive and HER2 negative, meeting specific test scores.

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I can take care of myself and am up and about more than half of my waking hours.

EVANGELINE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to 4 weeks, up to 12 weeks and up to end of treatment or up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to 4 weeks, up to 12 weeks and up to end of treatment or up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to 4 weeks, up to 12 weeks and up to end of treatment or up to 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Plasma

Treatment Cohort - Endocrine sensitive disease rate based on Ki-67 percent after 4 weeks of treatment

Secondary outcome measures

Both Cohorts - Change in estradiol and estrone

Both Cohorts - Incidence of Adverse Events Leading to Discontinuation

Both Cohorts - Incidence of Adverse Events assessed by CTCAE version 5.0

+23 more

EVANGELINE Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Cohort Arm 2 Modified RegimenExperimental Treatment2 Interventions

(Z)-endoxifen capsules orally once daily for 4 weeks + goserelin 3.6 mg by subcutaneous implant approximately every 28 days. (Z)-endoxifen dose will be based on the results of the PK Cohort. If Ki-67 ≤ 10% after 4 weeks of modified regimen, continue on this treatment for up to 6 total treatment cycles/Week 24. Each cycle is 28 days. If Ki-67 > 10% after 4 weeks of modified regimen, participant will be withdrawn and go on to surgery.

Group II: Treatment Cohort Arm 1 Modified RegimenExperimental Treatment2 Interventions

Group III: Treatment Cohort Arm 1 Initial RegimenExperimental Treatment1 Intervention

(Z)-endoxifen capsules orally once daily for 4 weeks. Dose will be based on the results of the PK Cohort. If Ki-67 ≤ 10% at Week 4, continue on this treatment for up to 6 cycles/Week 24. Each cycle is 28 days. If Ki-67 > 10% at Week 4, participant will be offered modified regimen or be withdrawn and go on to surgery.

Group IV: PK Cohort 80 mg + OFSExperimental Treatment2 Interventions

(Z)-endoxifen 80 mg capsules orally once daily for 4 weeks + goserelin 3.6 mg by subcutaneous implant approximately every 28 days. The PK Cohort participants may extend treatment based on Ki-67% at Week 4. If Ki-67 ≤ 10% at Week 4, participant will be offered option to continue on this treatment for up to 6 cycles/Week 24. Each cycle is 28 days. If Ki-67 > 10% at Week 4, participant will be withdrawn and go on to surgery.

Group V: PK Cohort 80 mgExperimental Treatment1 Intervention

(Z)-endoxifen 80 mg capsules orally once daily for 4 weeks. The PK Cohort participants may extend treatment based on Ki-67% at Week 4. If Ki-67 ≤ 10% at Week 4, participant will be offered option to continue on this treatment for up to 6 cycles/Week 24. Each cycle is 28 days. If Ki-67 > 10% at Week 4, participant will be withdrawn and go on to surgery.

Group VI: PK CohortExperimental Treatment1 Intervention

(Z)-endoxifen capsules orally once daily for 4 weeks. Initial (Z)-endoxifen dose evaluated will be 40 mg with an option to evaluate 20 mg or 80 mg. The PK Cohort participants may extend treatment based on Ki-67% at Week 4. If Ki-67 ≤ 10% at Week 4, participant will be offered option to continue on this treatment for up to 6 cycles/Week 24. Each cycle is 28 days. If Ki-67 > 10% at Week 4, participant will be withdrawn and go on to surgery.

Group VII: Treatment Cohort Arm 2 Initial RegimenActive Control2 Interventions

Exemestane 25 mg orally once daily for 4 weeks + goserelin 3.6 mg by subcutaneous implant approximately every 28 days. If Ki-67 ≤ 10% at Week 4, continue on this treatment for up to 6 cycles/Week 24. Each cycle is 28 days. If Ki-67 > 10% at Week 4, participant will be offered modified regimen or be withdrawn and go on to surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

goserelin

1999

Completed Phase 3

~5440

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

InClinUNKNOWN

Atossa Therapeutics, Inc.Lead Sponsor

7 Previous Clinical Trials

423 Total Patients Enrolled

1 Trials studying Breast Cancer

6 Patients Enrolled for Breast Cancer

Matthew P Goetz, MDPrincipal InvestigatorMayo Clinic

Media Library

Exemestane (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05607004 — Phase 2

Breast Cancer Research Study Groups: PK Cohort, Treatment Cohort Arm 2 Initial Regimen, Treatment Cohort Arm 1 Modified Regimen, Treatment Cohort Arm 2 Modified Regimen, PK Cohort 80 mg + OFS, Treatment Cohort Arm 1 Initial Regimen, PK Cohort 80 mg

Breast Cancer Clinical Trial 2023: Exemestane Highlights & Side Effects. Trial Name: NCT05607004 — Phase 2

Exemestane (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05607004 — Phase 2

Frequently Asked Questions

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

What risk factors are associated with Treatment Cohort Arm 1 Modified Regimen?

"Our team has assessed Treatment Cohort Arm 1 Modified Regimen as having a level 2 safety rating, since it is still in the Phase 2 trial stage and there are no confirmed reports of efficacy yet."

Answered by AI

What is the total number of individuals involved in this experiment?

"Affirmative. Clinicaltrials.gov states that this clinical trial, published on November 1st 2022, is actively searching for participants. The research team requires 174 patients from a single medical facility to enrol in the study."

Answered by AI

What are the main aims of this research endeavor?

"Atossa Therapeutics, Inc., the clinical trial sponsor, reports that the primary outcome measure of this experiment will be (Z)-endoxifen steady-state plasma concentrations over a 4 week treatment period. Secondary outcomes include changes in cholesterol levels from pre-neoadjuvant treatment, Maximum plasma (E)-endoxifen concentration and Time to plasma (E)-endoxifen maximum concentration for those who completed at least one cycle of treatment."

Answered by AI

Are there any vacancies in the clinical trial for volunteers?

"According to information hosted on clinicaltrials.gov, this research study is currently recruiting patients. The trial was posted online in November of 2022 and a recent update was made available on the 9th."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer

2023. "(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05607004.

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