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Metastatic Breast CancerPhase 3VERU-024NCT05065411

Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer

A Phase 3 study testing Enobosarm & Abemaciclib Combo and non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant in people with Metastatic Breast Cancer, run by Veru Inc. at 30 sites in United States.

Terminated

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

Official record
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Trial summary

STAGE 1: To determine the safety of enobosarm 9 milligram (mg) once daily (QD) used in combination with a CDK 4/6 inhibitor [Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)]. 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 & Abemaciclib Combo and non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
30 sitesUnited States
Study dates
11 Apr 2022to 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

  • Subjects accepted for this study must:
  • Provide informed consent
  • Be able to communicate effectively with the study personnel
  • Aged ≥18 years
  • For Female Subjects
  • Menopausal status
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  • 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 with a negative serum 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
  • For premenopausal and perimenopausal women where exemestane monotherapy or exemestane plus everolimus is chosen as the active control treatment patient must be already on ovarian suppression or to be candidates for this treatment: e.g., luteinizing hormone release hormone agonist or ovariectomy
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Documented evidence of ER+HER2- metastatic breast cancer (NOTE: patients with HER2+ metastatic breast cancer are excluded from participation in this study)
  • Measurable disease is required as per RECIST 1.1 (NOTE: Bone only metastatic disease is acceptable but requires a measurable component)
  • Have AR% nuclei staining ≥40% as assessed by central laboratory
  • Previously treated (and progressed on) with the following:
  • nonsteroidal aromatase inhibitor plus palbociclib for metastatic breast cancer OR
  • fulvestrant plus palbociclib for metastatic breast cancer
  • Subject is willing to comply with the requirements of the protocol through the end of the study
  • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization.
  • Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization
  • The patient is able to swallow oral medications
  • The patient has adequate organ function for all of the following criteria, as defined in Table 1 of the Protocol

Who cannot join

  • Any of the following conditions are cause for exclusion from the study:
  • Known hypersensitivity or allergy to enobosarm or abemaciclib
  • Patients with a biliary catheter
  • Creatinine clearance < 30 milliliter per minute (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.)
  • The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • 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
  • Testosterone, methyltestosterone, oxandrolone (Oxandrin®), oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens (flutamide, bicalutamide, abiraterone, enzalutamide, 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 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
  • Megestrol acetate
  • Testosterone
  • All other concurrent anticancer treatments (including, but not limited to, all SERMs, estrogen blocking agents unless randomized to Control Treatment Group, and CDK 4/6 inhibitors unless randomized to the abemaciclib in Enobosarm Combination Group)
  • An abnormal ECG result which, based on the investigator's clinical judgment, would place the subject at increased risk
  • The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  • 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 curatively 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
  • The patient has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Maryland Oncology Hematology, P.A.

    Annapolis, Maryland, 21401

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

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

    Cincinnati, Ohio, 45219

  • Texas Oncology, PA

    Dallas, Texas, 75246

  • Texas Oncology, PA

    Denton, Texas, 76201

  • Texas Oncology, P.A.

    El Paso, Texas, 79902

  • Summit Medical Group, Florham Park Campus

    Florham Park, New Jersey, 07932-1049

  • Texas Oncology, P.A.

    Flower Mound, Texas, 75028

  • Banner MDACC

    Gilbert, Arizona, 85234

  • UT MD Anderson CC

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39213

  • Los Angeles Cancer Network One Oncology

    Los Angeles, California, 90017

  • UCLA Parkside Cancer Center

    Los Angeles, California, 90095

  • Lakes Research

    Miami Lakes, Florida, 33014

  • Med OncologyHematology Consultants, PA Newark

    Newark, Delaware, 19713-7007

  • Virginia Oncology Assoc

    Norfolk, Virginia, 23502

  • UPMC Magee-Women's Hospital

    Pittsburgh, Pennsylvania, 15219

  • Renown Health

    Reno, Nevada, 89502

  • Texas Oncology, P.A.

    San Antonio, Texas, 78240

  • Sharp Center for Research

    San Diego, California, 92123

  • Sansum Clinic, CA

    Santa Barbara, California, 93105

  • University of Washington Seattle Cancer Center Alliance (SCCA)

    Seattle, Washington, 98109-1023

  • Cancer Care Northwest

    Spokane, Washington, 99216

  • Baystate Regional Cancer Program - D'Amour Center for Cancer Care

    Springfield, Massachusetts, 01199-1005

  • Washington University St. Louis

    St Louis, Missouri, 63110

  • Toledo Clinic Cancer Centers - Main Office

    Toledo, Ohio, 43623

  • Arizona Oncology Associates, PC-HOPE

    Tucson, Arizona, 85711

  • Texas Oncology, P.A.

    Tyler, Texas, 75702

  • The New York Hospital

    Westbury, New York, 11590

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

About this study

Official title: P3 Efficacy Evaluation of Enobosarm in Combo With Abemaciclib Compared to Estrogen Blocking Agent for 2nd Line Treatment of ER+HER2- MBC in Patients Who Have Shown Previous Disease Progression on an Estrogen Blocking Agent Plus Palbociclib

STAGE 1: To determine the safety of enobosarm 9 milligram (mg) once daily (QD) used in combination with a CDK 4/6 inhibitor [Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)].

STAGE 2: To demonstrate the efficacy and safety of enobosarm 9 mg QD in combination with abemaciclib 150 mg BID (Enobosarm Combination Group) versus Estrogen Blocking Agent (Control Treatment Group) in the treatment of estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), androgen receptor positive (AR+) with a AR% nuclei staining ≥40% metastatic breast cancer that have previously experienced disease progression on an estrogen blocking agent plus (palbociclib) as measured by progression free survival (PFS) according to RECIST 1.1 criteria.

Read the detailed description

STAGE 1: This is an open-label safety study of enobosarm 9 mg QD coadministered with a CDK 4/6 inhibitor (abemaciclib), 150 mg BID.

STAGE 2: This study is a multicenter, randomized, open-label, two treatment arm, efficacy and safety study. Subjects will be randomized to the two treatment arms (Enobosarm Combination Group versus Control Treatment Group) in a 1:1 fashion. The determination of the treatment to be used in the control arm will be declared prior to randomization.

If first line of therapy for metastatic breast cancer was a non-steroidal AI plus palbociclib, then the patient will be randomized to either enobosarm + abemaciclib OR fulvestrant.

If first line of therapy for metastatic breast cancer was fulvestrant plus palbociclib, then the patient will be randomized to either enobosarm + abemaciclib OR AI (steroidal or non-steroidal). If the patient is randomized to the Control Treatment Group to receive steroidal AI, (exemestane) the patient may receive exemestane with or without everolimus.

The primary efficacy endpoint of the study will be the median PFS as defined by RECIST 1.1.

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.

Long term survival follow up - every 30 days after last dose of study drug for 1 year and then every 90 days thereafter.

Being tested
Enobosarm & Abemaciclib Combo, non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Enobosarm & Abemaciclib ComboDrug

    Also called VERU-024, Verzenio

    Subjects will receive a combo of Enobosarm \& Abemaciclib

  • non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or FulvestrantDrug

    Also called exemestane, fulvestrant, exemestane plus everolimus

    Non-steroidal AI, a steroidal AI (exemestane with or without everolimus), OR fulvestrant

Study groups in NCT05065411
Study groupRoleWhat they receive
Enobosarm Combination GroupExperimentalEnobosarm Combination Group will receive enobosarm 9 mg each day by mouth (QD), and abemaciclib will administered by mouth at a dose of 150 mg BID. Stage 2 Subjects in the Enobosarm Combination Group will receive enobosarm 9 mg QD each day by mouth and abemaciclib 150 mg BID by mouth until disease progression is observed and confirmed by BICR.
Receives: Drug: Enobosarm & Abemaciclib Combo
Control Treatment GroupActive comparatorControl Treatment Group will receive a non-steroidal AI, a non-steroidal or steroidal (exemestane with or without everolimus), AI OR fulvestrant approved for the treatment of metastatic breast cancer and is part of the standard of care at the clinical study site until disease progression is observed and confirmed by BICR. The decision of which comparator treatment will be used will be made prior to randomization.
Receives: Drug: non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant

What is being measured

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

  1. Primary endpoint for the study is the median progression free survival (PFS) in the Enobosarm Combination Group compared to the Control Treatment Group in patients with AR% nuclei staining ≥40%. Progression will be defined based on RECIST 1.1 criteria

    STAGE 1: To determine the safety of enobosarm 9 mg once daily (QD) used in combination with abemaciclib tablets, for oral use, 150 mg twice daily (BID)].

    STAGE 2: To demonstrate the efficacy of enobosarm in combination with abemaciclib (Enobosarm Combination Group) versus an estrogen blocking agent, (non-steroidal AI, steroidal AI (exemestane with or without everolimus) or fulvestrant Control Treatment Group) in the treatment of AR+ER+HER2 (AR% nuclei staining ≥40%) metastatic breast cancer as measured by PFS according to RECIST 1.1.

    Measured: Day 1 to Day 300

Secondary outcomes (1)

  1. Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (partial response [PR] or complete response [CR]) on study

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

    Measured: Day 1 to Day 300

Timeline

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

  1. First posted4 Oct 2021
  2. Study start11 Apr 2022
  3. Primary completion19 Oct 2023
  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
Open Label two treatment arm
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05065411
Sponsor's protocol ID
V2000701
Acronym
VERU-024
Status last verified
Feb 2024
First submitted
21 Sep 2021
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
Yes
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 & Abemaciclib Combo and non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant in people with Metastatic Breast Cancer, run by Veru Inc. at 30 sites in United States.

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 30 inclusion and 21 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 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. 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?

Primary endpoint for the study is the median progression free survival (PFS) in the Enobosarm Combination Group compared to the Control Treatment Group in patients with AR% nuclei staining ≥40%. Progression will be defined based on RECIST 1.1 criteria (time frame: Day 1 to Day 300). 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 NCT05065411.

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 Feb 2024.

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