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

Status Recruiting

Clinical Trial Summary

This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal (still having periods) women with ER+/HER2- breast cancer. (Z)-endoxifen is a selective estrogen receptor modulator or "SERM." SERMs work to treat cancer by blocking the body's natural estrogen from binding to cancer cells. This study includes a pharmacokinetic part (PK, how the drug works in your body) and a treatment part. The primary purpose of the study is to see how (Z)-endoxifen works on tumor cell growth by monitoring a cancer marker called Ki-67. Ki-67 will be measured by biopsy of the breast after about 4 weeks of treatment. If your cancer is responding to treatment based on the Ki-67 results, you may continue treatment up to 24 weeks or until surgery. The PK part of the study will be enrolled first, enrolling about 18 study participants who will all receive oral once daily (Z)-endoxifen treatment. 12 of these participants will be randomly assigned to treatment with an equal (50/50) chance to be assigned to (Z)-endoxifen or (Z)-endoxifen + goserelin (a medication given to block the ovaries from making estrogen and is also called ovarian suppression). This part of the study will help select the dose of (Z)-endoxifen to use in the treatment part by measuring the levels of (Z)-endoxifen in the blood stream and determine how long it takes for the body to remove it. About 160 study participants will be enrolled in the treatment part. The treatment part will help to determine how oral once daily (Z)-endoxifen, when taken by itself, compares to oral once daily exemestane (a medication that decreases the amount of estrogen in the body, also known as an aromatase inhibitor) and monthly injections of goserelin. Exemestane and goserelin taken together is a standard treatment regimen for premenopausal patients with ER+/HER2- breast cancer. Study participants are randomly assigned to treatment with an equal (50/50) chance to be assigned to (Z)-endoxifen or standard treatment. Study participation is up to 24 weeks of treatment followed by surgery.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05607004
Study type	Interventional
Source	Atossa Therapeutics, Inc.
Contact	Arezoo Mirad, MD, MS
Phone	650-647-4913
Email	Arezoo.Mirad@Atossainc.com
Status	Recruiting
Phase	Phase 2
Start date	February 14, 2023
Completion date	September 2026

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05558917` - Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery	N/A
Active, not recruiting	`NCT03664778` - Abbreviated Breast MRI After Cancer Treatment
Recruiting	`NCT03144622` - 18F-FSPG PET/CT Imaging in Patients With Cancers
Completed	`NCT05452499` - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae	N/A
Active, not recruiting	`NCT04568902` - Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer	Phase 1
Completed	`NCT02860585` - Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation	N/A
Completed	`NCT04059809` - Photobiomodulation for Breast Cancer Radiodermatitis	Phase 2/Phase 3
Recruiting	`NCT04557449` - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors	Phase 1/Phase 2
Completed	`NCT03698942` - Delphinus SoftVue™ ROC Reader Study
Completed	`NCT00092950` - Exercise in Women at Risk for Breast Cancer	Phase 2
Withdrawn	`NCT04123704` - Sitravatinib in Metastatic Breast Cancer	Phase 2
Not yet recruiting	`NCT02151071` - The Breast Surgery EnLight and LightPath Imaging System Study	Phase 1/Phase 2
Recruiting	`NCT02934360` - TR(ACE) Assay Clinical Specimen Study	N/A
Active, not recruiting	`NCT02950064` - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations	Phase 1
Completed	`NCT02931552` - Nuevo Amanecer II: Translating a Stress Management Program for Latinas	N/A
Not yet recruiting	`NCT02876848` - A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)	N/A
Recruiting	`NCT02547545` - Breast Cancer Chemotherapy Risk Prediction Mathematical Model	N/A
Completed	`NCT02518477` - Preventive Intervention Against Lymphedema After Breast Cancer Surgery	N/A
Completed	`NCT02652975` - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium	N/A
Completed	`NCT02303366` - Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms