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

Stopped early · Phase 3

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT05065411

Run by

Veru Inc.

People needed

5

Starts

2022-04-11

Expected to finish

2024-01-09

Last updated by the study team

2024-02-26

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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.
• 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.

Where it is running

• Ironwood Cancer & Research Centers — Chandler, Arizona, United States
• Banner MDACC — Gilbert, Arizona, United States
• Arizona Oncology Associates, PC-HOPE — Tucson, Arizona, United States
• Los Angeles Cancer Network One Oncology — Los Angeles, California, United States
• UCLA Parkside Cancer Center — Los Angeles, California, United States
• Sharp Center for Research — San Diego, California, United States
• Sansum Clinic, CA — Santa Barbara, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• Med OncologyHematology Consultants, PA Newark — Newark, Delaware, United States
• Lakes Research — Miami Lakes, Florida, United States
• Maryland Oncology Hematology, P.A. — Annapolis, Maryland, United States
• Baystate Regional Cancer Program - D'Amour Center for Cancer Care — Springfield, Massachusetts, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Washington University St. Louis — St Louis, Missouri, United States
• Renown Health — Reno, Nevada, United States
• Summit Medical Group, Florham Park Campus — Florham Park, New Jersey, United States
• The New York Hospital — Westbury, New York, United States
• The Lindner Center for Research and Education at the Christ Hospital — Cincinnati, Ohio, United States
• Toledo Clinic Cancer Centers - Main Office — Toledo, Ohio, United States
• UPMC Magee-Women's Hospital — Pittsburgh, Pennsylvania, United States
• Texas Oncology, PA — Dallas, Texas, United States
• Texas Oncology, PA — Denton, Texas, United States
• Texas Oncology, P.A. — El Paso, Texas, United States
• Texas Oncology, P.A. — Flower Mound, Texas, United States
• UT MD Anderson CC — Houston, Texas, United States

Full record on ClinicalTrials.gov

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