Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer

NCT04869943 | Terminated Phase 3 FDA Drug

• 1 other identifier: V3002401
• Study Type: interventional
• Target: 52
• Locations: 4 countries
• Sites: 54

Brief Summary

To demonstrate the efficacy of enobosarmin the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).

Conditions

Metastatic Breast Cancer

Keywords

Third line; 3rd line; Androgen Receptor

Outcome Measures

Primary Outcomes (1)

• To demonstrate the efficacy of Enobosarm in the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).

  The primary endpoint for the study is the median radiographic progression free survival (rPFS) in the Enobosarm Treatment Group compared to the Control Treatment Group. Progression will be defined based on RECIST 1.1.

  Day 120

Secondary Outcomes (1)

• Objective Response Rate (ORR)

  Day 180

Study Arms (2)

Enobosarm Treatment Group

EXPERIMENTAL

Subjects in the Enobosarm Treatment Group will receive enobosarm 9mg each day by mouth until disease progression or an unacceptable adverse event is observed. The total duration of the study for a subject in the study from screening to follow-up visit is not standardized and will be different for each subject.

Drug: Enobosarm

Control Treatment Group

ACTIVE COMPARATOR

Subjects in the Control Treatment Group will receive an ER targeted therapy limited to exemestane monotherapy, exemestane plus everolimus or selective estrogen receptor modulator (SERM) approved for the treatment of breast cancer and is part of the standard of care at the clinical study site. The decision of which comparator treatment will be used will be made prior to randomization. After radiographic progression, subjects randomized to the Control Treatment Group may be crossed over to receive enobosarm 9mg.

Drug: Exemestane

Interventions

Enobosarm DRUG

Oral Enobosarm 9mg per day

Also known as: VERU-024

Enobosarm Treatment Group

Exemestane DRUG

Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator (SERM)

Also known as: Mestane

Control Treatment Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent
• Be able to communicate effectively with the study personnel
• Aged ≥18 years
• For Female Subjects
• Menopausal status
• Be postmenopausal as defined by the National Comprehensive Cancer Network as either:
• Age ≥55 years and one year or more of amenorrhea
• Age \<55 years and one year or more of amenorrhea, with an estradiol assay \<20 pg/mL
• Age \<55 years and surgical menopause with bilateral oophorectomy
• Be premenopausal or perimenopausal on ovarian suppression with LHRH agonist for at least 4 months, with an estradiol assay \<20 pg/mL and a negative urine pregnancy test.
• If subject is of child bearing potential, the subject must agree to use acceptable methods of contraception:
• If female study participant could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository \[i.e., barrier method of contraception\], surgical sterilization of male partner (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}
• If female study participant has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used
• If female study participant has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used
• For Male Subjects

You may not qualify if:

• Known hypersensitivity or allergy to enobosarm
• Patients with biliary catheter.
• Creatinine clearance \< 30 mL/min as measured using the Cockcoft Gault formula (patients with mild and moderate renal failure are not excluded from participation in this study)
• Previously received \>1 course of systemic chemotherapy (not including immunotherapies or targeted therapies) for the treatment of metastatic breast cancer.
• Note: Subjects may have received 1 course of chemotherapy in the adjuvant or neoadjuvant setting would not count as a line of therapy.
• Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by CT or MRI that are not well-controlled (symptomatic or requiring control with continuous corticosteroid therapy \[e.g., dexamethasone\]) Note: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well-controlled and stable for at least 30 days after receiving local therapy (irradiation, surgery, etc.)
• Radiotherapy within 14 days prior to randomization except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization
• Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, severe renal impairment, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
• Treatment with any investigational product within \< 4 half-lives for each individual investigational product OR within 30 days prior to randomization
• Major surgery within 30 days prior to randomization
• Treatment with testosterone, methyltestosterone, oxandrolone (Oxandrin®), oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens (enzalutamide, abiraterone, bicalutamide, apalutamide, or darolutamide). Previous therapy with testosterone and testosterone-like agents is acceptable with a 30-day washout (if previous testosterone therapy was long term depot within the past 6 months, the site should contact the Medical Monitor) or any other androgenic agent.
• Treatment with any of the following hormone replacement therapies for metastatic breast cancer. Prior use in the adjuvant or neoadjuvant setting is allowed if the treatment is, discontinued greater than 30 days prior to randomization
• Estrogens
• Megesterol acetate
• Testosterone

Sponsors & Collaborators

• Veru Inc.: lead

Study Sites (54)

Ironwood Cancer and Research Centers

Chandler, Arizona, 85224, United States

Location

Banner Health/ Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

The Oncology Insitute of Hope and Innovation

Glendale, California, 91204, United States

Location

Marin Cancer Care, Inc.

Greenbrae, California, 94904, United States

Location

California Research Institute (CRI)

Los Angeles, California, 90027, United States

Location

University of California San Francisco Comprehensive Cancer Center

San Francisco, California, 94158, United States

Location

Providence Medical Group

Santa Rosa, California, 95043, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 81008, United States

Location

Morton Plant Hospital/ BayCare Health System, Inc

Clearwater, Florida, 33756, United States

Location

University of Miami- Sylvester Comprehensive Cancer Center

Miami, Florida, 33146, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Woodlands Medical Specialists, PA

Pensacola, Florida, 32503, United States

Location

Miami Cancer Institute, Plantation MCIP

Plantation, Florida, 33324, United States

Location

University Cancer & Blood Center

Athens, Georgia, 30607, United States

Location

Blessing Corporate Services

Quincy, Illinois, 62301, United States

Location

MBCCOP - LSU Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Dana-Farber Cancer Institute Breast Oncology

Boston, Massachusetts, 02215, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

Location

Inspira Medical Center Mullica Hill

Mullica Hill, New Jersey, 08062, United States

Location

Inspira Medical Center

Vineland, New Jersey, 08360, United States

Location

The Lindner Center for Research and Education at the Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Magee-Women's Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Tidelands Health

Murrells Inlet, South Carolina, 29576, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37909, United States

Location

Baptist Clinical Research Institute

Nashville, Tennessee, 38102, United States

Location

Texas Oncology Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

Location

MultiCare Institute for Research and Innovation

Puyallup, Washington, 98372, United States

Location

Cancer Care Northwest

Spokane, Washington, 99216, United States

Location

MultiCare Institute for Research and Innovation

Spokane, Washington, 99218, United States

Location

Wojewódzka Przychodnia Onkologiczna, Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

Lodz, 91-211, Poland

Location

Instytut Centrum Zdrowia Matki Polki

Lodz, 93-338, Poland

Location

Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

Lublin, 20-090, Poland

Location

Specjalistyczny Szpital Onkologiczny NU-MED

Maków Mazowiecki, 97-200, Poland

Location

"Oddział Onkologii Klinicznej i Chemioterapii Europejskie Centrum Zdrowia Otwock"

Otwock, 05-400, Poland

Location

Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy

Warsaw, 02-781, Poland

Location

A Coruña University Hospital

A Coruña, Spain

Location

Hospital Universitari Dexeus

Barcelona, 08028, Spain

Location

Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)

Barcelona, 08035, Spain

Location

Institut Catala d'Oncologia (ICO)

Barcelona, 08908, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, 25198, Spain

Location

Hospital Ruber Internacional

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre (H12O)

Madrid, 28041, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Clínico Universitario de Valencia (CHUV)

Valencia, 46010, Spain

Location

Municipal Institution "Dnipropetrovsk City Multi-field Clinical Hospital #4", Dnepropetrovsk state m

Dnipro, 49000, Ukraine

Location

State institution "V.T. Zaycev Institute of general and urgent surgery of National academy medical sciences of Ukraine"

Kharkiv, 61103, Ukraine

Location

Khmelnytsky Regional Antitumor Center, Department of Breast, Skin, Soft Tissues and Bones Tumorsa

Khmelnytskyi, 29000, Ukraine

Location

Kyiv City Clinical Oncology Center

Kyiv, 03115, Ukraine

Location

Odessa Regional Oncological Dispensary

Odesa, 65000, Ukraine

Location

MeSH Terms

Conditions

Breast Neoplasms; Bulbo-Spinal Atrophy, X-Linked

Interventions

ostarine; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Barnette

  Veru Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects in the Enobosarm Treatment Group will receive enobosarm 9mg each day by mouth until disease progression or an unacceptable adverse event is observed. Subjects in the Control Treatment Group will receive a ER targeted therapy limited to exemestane monotherapy, exemestane plus everolimus or selective estrogen receptor modulator(SERM) approved for the treatment of breast cancer and is part of the standard of care at the clinical study site. The decision of which comparator treatment will be used will be made prior to randomization.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 3, 2021
• Study Start: October 12, 2021
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

ES (9); UA (5); PL (6); US (34)