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Endoxifen for Breast Cancer (EVANGELINE Trial)
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.
EVANGELINE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEVANGELINE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EVANGELINE Trial Design
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Who is running the clinical trial?
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- My breast cancer is low or intermediate grade.My breast cancer is ER positive and HER2 negative, meeting specific test scores.I do not have serious ongoing health issues that are not under control.My breast cancer is at stage IIA or IIB.I have not had breast cancer or any other cancer in the last 2 years.I am not on hormonal therapies, including birth control or hormone replacement, and won't be during the study.My breast cancer is at stage T2 or T3 and has spread to nearby lymph nodes.I have inflammatory breast cancer, possibly in both breasts.I am a premenopausal woman aged 18 or older.My breast cancer is ER positive and HER2 negative, meeting specific test scores.My cancer has spread to other parts of my body.I can take care of myself and am up and about more than half of my waking hours.
- Group 1: PK Cohort
- Group 2: Treatment Cohort Arm 2 Initial Regimen
- Group 3: Treatment Cohort Arm 1 Modified Regimen
- Group 4: Treatment Cohort Arm 2 Modified Regimen
- Group 5: PK Cohort 80 mg + OFS
- Group 6: Treatment Cohort Arm 1 Initial Regimen
- Group 7: PK Cohort 80 mg
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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