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Metastatic Breast CancerPhase 3ARTESTNCT04869943

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

A Phase 3 study testing Enobosarm and Exemestane in people with Metastatic Breast Cancer, run by Veru Inc. at 54 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Enobosarm and Exemestane
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
54 sitesin 4 countries
Study dates
12 Oct 2021to 9 Jan 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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
  • Subject must agree to use acceptable methods of contraception:
  • If the study subject's partner 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 (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)
  • If female partner of a study subject 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 partner of a study subject 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Documented evidence of ER+/HER2- metastatic breast cancer
  • Measurable disease is required as per RECIST 1.1 (NOTE: Bone only metastatic disease is acceptable but requires a measurable component
  • Have androgen receptor nuclei staining ≥40% as assessed by central laboratory
  • Received at least 2 prior lines of treatment in MBC setting which must have included both an AI (monotherapy or combination) and fulvestrant (monotherapy or combination); at least one must have been given in combination with a CDK 4/6 inhibitor.
  • Previously responded (without disease progression for at least 6 months) to one of the following treatments: fulvestrant monotherapy or fulvestrant plus CDK 4/6 inhibitor or nonsteroidal aromatase inhibitor monotherapy or nonsteroidal aromatase inhibitor plus CDK 4/6 inhibitor for metastatic breast cancer.
  • Subject is willing to comply with the requirements of the protocol through the end of the study

Who cannot join

  • Known hypersensitivity or allergy to enobosarm
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 X upper limit of normal (ULN) or total bilirubin >ULN (an elevated total bilirubin up to 1.5 X ULN attributed to a previously confirmed diagnosis of Gilbert's disease is acceptable if all other eligibility criteria are met). In patients with documented metastases to the liver, the limits for inclusion are ALT or AST >5.0 X ULN or total bilirubin >1.5 X ULN.
  • 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.
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  • 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
  • All other concurrent anticancer treatments (including, but not limited to, all SERMs unless randomized to the Control Treatment Group with a SERM as the control treatment, AIs unless randomized to Control Treatment Group (exemestane or exemestane plus everolimus) with the AI containing treatment as the control treatment, and all CDK 4/6 inhibitors)
  • An abnormal ECG result which, based on the investigator's clinical judgment, would place the subject at increased risk
  • Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years [note: subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal breast carcinoma in situ, bladder cancer (superficial treated), or cervical carcinoma in situ that have undergone potentially curative therapy are not excluded]
  • Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment

Trial locations and contacts

54 sites in 4 countries.

54 sites in 4 countries

United States34 sites

  • University Cancer & Blood Center

    Athens, Georgia, 30607

  • Dana-Farber Cancer Institute Breast Oncology

    Boston, Massachusetts, 02215

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • The Lindner Center for Research and Education at the Christ Hospital

    Cincinnati, Ohio, 45219

  • Morton Plant Hospital/ BayCare Health System, Inc

    Clearwater, Florida, 33756

  • Texas Oncology Sammons Cancer Center

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 81008

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Banner Health/ Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • The Oncology Insitute of Hope and Innovation

    Glendale, California, 91204

  • Marin Cancer Care, Inc.

    Greenbrae, California, 94904

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • California Research Institute (CRI)

    Los Angeles, California, 90027

  • University of Miami- Sylvester Comprehensive Cancer Center

    Miami, Florida, 33146

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Inspira Medical Center Mullica Hill

    Mullica Hill, New Jersey, 08062

  • Tidelands Health

    Murrells Inlet, South Carolina, 29576

  • Baptist Clinical Research Institute

    Nashville, Tennessee, 38102

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503

  • Magee-Women's Hospital

    Pittsburgh, Pennsylvania, 15219

  • Miami Cancer Institute, Plantation MCIP

    Plantation, Florida, 33324

  • MultiCare Institute for Research and Innovation

    Puyallup, Washington, 98372

  • Blessing Corporate Services

    Quincy, Illinois, 62301

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia, 24014

  • University of California San Francisco Comprehensive Cancer Center

    San Francisco, California, 94158

  • Providence Medical Group

    Santa Rosa, California, 95043

  • MBCCOP - LSU Health Sciences Center

    Shreveport, Louisiana, 71103

  • Cancer Care Northwest

    Spokane, Washington, 99216

  • MultiCare Institute for Research and Innovation

    Spokane, Washington, 99218

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Inspira Medical Center

    Vineland, New Jersey, 08360

Other trials in United States

Spain9 sites

  • A Coruña University Hospital

    A Coruña

  • Hospital Universitari Dexeus

    Barcelona, 08028

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

    Barcelona, 08035

  • Institut Catala d'Oncologia (ICO)

    Barcelona, 08908

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hospital Ruber Internacional

    Madrid, 28034

  • Hospital Universitario 12 de Octubre (H12O)

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Clínico Universitario de Valencia (CHUV)

    Valencia, 46010

Other trials in Spain

Poland6 sites

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

    Lodz, 91-211

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

    Lublin, 20-090

  • Specjalistyczny Szpital Onkologiczny NU-MED

    Maków Mazowiecki, 97-200

  • "Oddział Onkologii Klinicznej i Chemioterapii Europejskie Centrum Zdrowia Otwock"

    Otwock, 05-400

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

    Warsaw, 02-781

Other trials in Poland

Ukraine5 sites

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

    Dnipro, 49000

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

    Kharkiv, 61103

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

    Khmelnytskyi, 29000

  • Kyiv City Clinical Oncology Center

    Kyiv, 03115

  • Odessa Regional Oncological Dispensary

    Odesa, 65000

Other trials in Ukraine

About this study

Official title: Randomized Crossover Ph3 to Evaluate Efficacy/Safety of Enobosarm Monotherapy vs Active Control for Treatment of AR+/ER+/HER2- MBC With AR Staining Previously Treated w/Nonsteroidal Aromatase Inhibitor, SERD & CDK 4/6 Inhibitor

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).

Read the detailed description

This study is a multicenter, randomized, open-label, two treatment arm, efficacy and safety study, comprised of two sections, the main study and the post-study extension period. Subjects will be randomized to the two treatment arms in a 1:1 fashion (into the main study), with the opportunity for subjects initially randomized to the Control Treatment Group to cross over to receive the investigational treatment in the post-study extension period.

The primary efficacy endpoint of the study will be the median rPFS. Subjects will continue study treatment until disease progression confirmed by blinded independent central reader (BICR) is observed. A safety follow up visit will occur approximately 30 days after last dose of study drug. Thereafter, survival follow up will be completed monthly for one year. Survival follow up may be completed by phone or records review. After one year, survival follow up will be completed every 90 days.

After radiographic progression (by RECIST 1.1) is confirmed by blinded independent central reader (BICR) and have received approval from Medical Monitor, subjects in the Control Treatment Group may be crossed over to receive enobosarm treatment (9mg per day). Treatment will continue in this population (Enobosarm Post-study Group (EPG)) until radiographic progression (by RECIST 1.1), confirmed by BICR, is observed. The efficacy database for this crossover group will be completely separate from the main portion of the study and the data will be analyzed separately.

Being tested
Enobosarm, Exemestane
Keywords
Third line, 3rd line, Androgen Receptor
Medical subject headings
Breast Neoplasms, Bulbo-Spinal Atrophy, X-Linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnobosarmDrug

    Also called VERU-024

    Oral Enobosarm 9mg per day

  • ExemestaneDrug

    Also called Mestane

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

Study groups in NCT04869943
Study groupRoleWhat they receive
Enobosarm Treatment GroupExperimentalSubjects 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.
Receives: Drug: Enobosarm
Control Treatment GroupActive comparatorSubjects 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.
Receives: Drug: Exemestane

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 120

Secondary outcomes (1)

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (PR or CR) on study

    Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2021
  2. Study start12 Oct 2021
  3. Primary completion9 Jan 2024
  4. Study completion9 Jan 2024

Why it stopped: Business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04869943
Sponsor's protocol ID
V3002401
Acronym
ARTEST
Status last verified
Jan 2024
First submitted
27 Apr 2021
Last updated
26 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enobosarm and Exemestane in people with Metastatic Breast Cancer, run by Veru Inc. at 54 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Spain, Poland, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Day 120). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04869943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.

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