Breast Cancer Clinical Trial

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

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)].

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 pgmL Age <55 surgical menopause 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

Exclusion Criteria:

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> 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.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

186

Study ID:

NCT05065411

Recruitment Status:

Recruiting

Sponsor:

Veru Inc.

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There are 29 Locations for this study

See Locations Near You

Ironwood Cancer & Research Centers
Chandler Arizona, 85224, United States More Info
Andrea R Garcia
Contact
480-398-7671
[email protected]
Sujith Kalmadi
Principal Investigator
Banner MDACC
Gilbert Arizona, 85234, United States More Info
Lisa Sloan
Contact
480-256-5437
[email protected]
Skakeela Bahadur
Principal Investigator
Arizona Oncology Associates, PC-HOPE
Tucson Arizona, 85711, United States More Info
Stacey Kimbell
Contact
520-886-0206
[email protected]
Aisha Ahmed
Principal Investigator
Los Angeles Cancer Network One Oncology
Los Angeles California, 90017, United States More Info
Lasika Seneviratne
Principal Investigator
UCLA Parkside Cancer Center
Los Angeles California, 90095, United States More Info
Lauren Zelman
Contact
424-440-3877
[email protected]
Sara Hurvitz
Principal Investigator
The Oncology Institute of Hope & Innovation
Lynwood California, 90262, United States More Info
Kirsten Bettino
Contact
562-693-4477
[email protected]
Michael Chung
Principal Investigator
Sharp Center for Research
San Diego California, 92123, United States More Info
Galen Steinhoff
Contact
858-939-7201
[email protected]
Edward Huynh
Principal Investigator
Sansum Clinic, CA
Santa Barbara California, 93105, United States More Info
Heidi Heitkamp
Contact
[email protected]
Maira Campos
Principal Investigator
Med OncologyHematology Consultants, PA Newark
Newark Delaware, 19713, United States More Info
Denise DeMaio
Contact
302-366-1200
[email protected]
Jamal Misleh
Principal Investigator
Lakes Research
Miami Lakes Florida, 33014, United States More Info
Yamile Sanchez
Contact
786-362-5763
[email protected]
Eloy Roman
Principal Investigator
Maryland Oncology Hematology, P.A.
Annapolis Maryland, 21401, United States More Info
Jennifer Cipriano
Contact
301-424-6231
[email protected]
Jeanine Werner
Principal Investigator
Baystate Regional Cancer Program - D'Amour Center for Cancer Care
Springfield Massachusetts, 01199, United States More Info
Katherine Colbeck
Contact
413-794-5433
[email protected]
Grace Makari-Judson
Principal Investigator
University of Mississippi Medical Center
Jackson Mississippi, 39213, United States More Info
Jennifer Barnes
Contact
601-815-4540
[email protected]
Shou-Ching Tang
Principal Investigator
Washington University St. Louis
Saint Louis Missouri, 63110, United States More Info
Leslie Nehring
Contact
314-362-9679
[email protected]
Bisi Ademuyiwa
Principal Investigator
Renown Health
Reno Nevada, 89502, United States More Info
Amil Trujillo-King
Contact
775-742-7753
[email protected]
Lee Schwartzberg
Principal Investigator
Summit Medical Group, Florham Park Campus
Florham Park New Jersey, 07932, United States More Info
Michelle Mackenzie
Contact
973-436-1755
[email protected]
Steven Papish
Principal Investigator
The New York Hospital
Westbury New York, 11590, United States More Info
Judith Lovecchio
Contact
516-488-2918
[email protected]
Morton Coleman
Principal Investigator
The Lindner Center for Research and Education at the Christ Hospital
Cincinnati Ohio, 45219, United States More Info
Abby Reed
Contact
513-585-4203
[email protected]
Gina Chung
Principal Investigator
Toledo Clinic Cancer Centers - Main Office
Toledo Ohio, 43623, United States More Info
Jennifer Martinez
Contact
312-967-4387
[email protected]
Rex Mowat
Principal Investigator
UPMC Magee-Women's Hospital
Pittsburgh Pennsylvania, 15219, United States More Info
Brenda Steele
Contact
412-641-3418
[email protected]
Adam Brufsky
Principal Investigator
Texas Oncology, PA
Dallas Texas, 75246, United States More Info
Ceryce Ford
Contact
214-370-1000
[email protected]
Joyce O' Shaunassey
Principal Investigator
Texas Oncology, PA
Denton Texas, 76201, United States More Info
Nancy Smith
Contact
940-382-1022
[email protected]
Charles Kurkul
Principal Investigator
Texas Oncology, P.A.
El Paso Texas, 79902, United States More Info
Tanya Jauch-Worley
Contact
915-544-6750
[email protected]
Ines Sanchez-Rivera
Principal Investigator
Texas Oncology, P.A.
Flower Mound Texas, 75028, United States More Info
Barbara Lane
Contact
972-537-4100
[email protected]
Thomas Vibha
Principal Investigator
UT MD Anderson CC
Houston Texas, 77030, United States More Info
Olaia Kizzee
Contact
713-792-4550
[email protected]
Naoto Ueno
Principal Investigator
Texas Oncology, P.A.
San Antonio Texas, 78240, United States More Info
Christine Korn
Contact
972-537-4100
[email protected]
Emmalind Aponte
Principal Investigator
Texas Oncology, P.A.
Tyler Texas, 75702, United States More Info
Shelly Maxfield
Contact
903-579-9800
[email protected]
Sasha Davis
Principal Investigator
Virginia Oncology Assoc
Norfolk Virginia, 23502, United States More Info
Wendi O Gobhardt
Contact
757-466-8663
[email protected]
Michael Danso
Principal Investigator
Cancer Care Northwest
Spokane Washington, 99216, United States More Info
Ronaye Wagner
Contact
509-228-1682
[email protected]
Kristine Rinn
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

186

Study ID:

NCT05065411

Recruitment Status:

Recruiting

Sponsor:


Veru Inc.

How clear is this clinincal trial information?

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