Breast Cancer Clinical Trial

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

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).

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 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 pgmL 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

Exclusion Criteria:

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.

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

210

Study ID:

NCT04869943

Recruitment Status:

Recruiting

Sponsor:

Veru Inc.

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There are 58 Locations for this study

See Locations Near You

Alaska Oncology and Hematology, LLC.
Anchorage Alaska, 99508, United States
Ironwood Cancer and Research Centers
Chandler Arizona, 85224, United States More Info
Andrea Garcia
Contact
480-398-7671
[email protected]
Sujith Kalmadi
Principal Investigator
Banner Health/ Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Bryan Crabtree
Contact
480-256-5411
[email protected]
Qing Zhao
Principal Investigator
The Oncology Insitute of Hope and Innovation
Glendale California, 91204, United States More Info
Kirsten Bettino
Contact
818-844-1678
[email protected]
Paul La Porte
Principal Investigator
Marin Cancer Care, Inc.
Greenbrae California, 94904, United States More Info
Jaime Chung
Contact
415-925-5040
[email protected]
Kristin Anderson
Principal Investigator
California Research Institute (CRI)
Los Angeles California, 90027, United States
University of California San Francisco Comprehensive Cancer Center
San Francisco California, 94158, United States More Info
Amy DeLuca
Contact
415-353-7288
[email protected]
Hope Rugo
Principal Investigator
Providence Medical Group
Santa Rosa California, 95043, United States More Info
Teresa Lund
Contact
707-888-1460
[email protected]
Jarrod Holmes
Principal Investigator
Rocky Mountain Cancer Centers
Denver Colorado, 81008, United States More Info
Jennifer Hege
Contact
303-385-2067
[email protected]
Jenny Fox
Principal Investigator
GenesisCare USA
Aventura Florida, 33180, United States
Morton Plant Hospital/ BayCare Health System, Inc
Clearwater Florida, 33756, United States More Info
Jennifer Boyd
Contact
727-461-8519
[email protected]
Ben Yan
Principal Investigator
University of Miami- Sylvester Comprehensive Cancer Center
Miami Florida, 33146, United States More Info
Onaidy T Torres
Contact
305-243-6823
[email protected]
Elisa Krill Jackson
Principal Investigator
Miami Cancer Institute
Miami Florida, 33176, United States More Info
Xiaoou Pan
Contact
786-527-8861
[email protected]
Lauren Carcas
Principal Investigator
Woodlands Medical Specialists, PA
Pensacola Florida, 32503, United States More Info
Leslie Bellamy
Contact
850-696-4423
[email protected]
Rami Owera
Principal Investigator
Miami Cancer Institute, Plantation MCIP
Plantation Florida, 33324, United States More Info
Jhonny Gonzalez
Contact
954-837-1566
[email protected]
Lauren Carcas
Principal Investigator
University Cancer & Blood Center
Athens Georgia, 30607, United States More Info
Nikki Cooper
Contact
706-353-2990
[email protected]
Gustavo Westin
Principal Investigator
Blessing Corporate Services
Quincy Illinois, 62301, United States More Info
Kiley McGlauchlen
Contact
217-223-8400
[email protected]
Kellie Flippin
Principal Investigator
MBCCOP - LSU Health Sciences Center
Shreveport Louisiana, 71103, United States More Info
Lisa McCary
Contact
318-813-1465
[email protected]
Gary Burton
Principal Investigator
Dana-Farber Cancer Institute Breast Oncology
Boston Massachusetts, 02215, United States More Info
Nicole Ryabin
Contact
617-495-1000
[email protected]
Erica Mayer
Principal Investigator
Revive Research Institute
Farmington Hills Michigan, 48073, United States
Sikar Grewal
Sterling Heights Michigan, 48314, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States More Info
Trisha Vincent
Contact
702-952-3400
[email protected]
Liawaty Ho
Principal Investigator
Astera Cancer Care
East Brunswick New Jersey, 08816, United States More Info
Percy Yeung
Contact
732-390-7750
[email protected]
Bruno Fang
Principal Investigator
Inspira Medical Center Mullica Hill
Mullica Hill New Jersey, 08062, United States More Info
Catherine M Vazquez
Contact
609-774-2618
[email protected]
Erev Tubb
Principal Investigator
Inspira Medical Center
Vineland New Jersey, 08360, United States More Info
Sami Abate
Contact
856-641-7526
[email protected]
Mylene Go
Principal Investigator
The Lindner Center for Research and Education at the Christ Hospital
Cincinnati Ohio, 45219, United States More Info
Abby Reed
Contact
513-585-1140
[email protected]
Gina Chung
Principal Investigator
Magee-Women's Hospital
Pittsburgh Pennsylvania, 15219, United States More Info
Lucia Borrasso
Contact
412-641-3304
[email protected]
Adam Brufsky
Principal Investigator
Tidelands Health
Murrells Inlet South Carolina, 29576, United States More Info
Barbara Roe
Contact
843-652-1607
[email protected]
Sara Adams
Principal Investigator
Tennessee Cancer Specialists
Knoxville Tennessee, 37909, United States More Info
Whitney Henderson
Contact
865-934-2674
[email protected]
Robert D Schumaker
Principal Investigator
Baptist Clinical Research Institute
Nashville Tennessee, 38102, United States More Info
Mariesha Williams
Contact
901-226-1471
[email protected]
Phillip Lammers
Principal Investigator
Texas Oncology Sammons Cancer Center
Dallas Texas, 75246, United States More Info
Melissa Melendez-Salazar
Contact
214-370-1000
[email protected]
Joyce O'Shaunnessy
Principal Investigator
Texas Oncology - Tyler
Tyler Texas, 75702, United States More Info
Shelly Maxfield
Contact
903-579-9800
[email protected]
Sasha Davis
Principal Investigator
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States More Info
Carrie Friedman
Contact
703-636-1473
[email protected]
Anne Favret
Principal Investigator
Virginia Oncology Associates
Norfolk Virginia, 23502, United States More Info
Angel Kidd
Contact
757-368-5033
[email protected]
Michael Danso
Principal Investigator
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke Virginia, 24014, United States More Info
Natasha Holt
Contact
276-228-7665
[email protected]
Amanda Gillespie-Twardy
Principal Investigator
MultiCare Institute for Research and Innovation
Puyallup Washington, 98372, United States More Info
Danielle Wahinekapu
Contact
253-697-1310
[email protected]
Meghana Bansal
Principal Investigator
University of Washington
Seattle Washington, 98109, United States
Cancer Care Northwest
Spokane Washington, 99216, United States More Info
Bethany Giachetti
Contact
509-228-1684
[email protected]
Kristine Rinn
Principal Investigator
MultiCare Institute for Research and Innovation
Spokane Washington, 99218, United States More Info
Jalene Tangen
Contact
509-228-2103
[email protected]
Meghana Bansal
Principal Investigator
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin , 20-09, Poland More Info
Tomasz Kozdra
Contact
48 814541029
[email protected]
Aneta Dobrzyńska-Rutkowska
Principal Investigator
Specjalistyczny Szpital Onkologiczny NU-MED
Maków Mazowiecki , 97-20, Poland More Info
Beata Glogowska
Contact
4844 7868160
[email protected]
Ewa Chmielowska
Principal Investigator
"Oddział Onkologii Klinicznej i Chemioterapii Europejskie Centrum Zdrowia Otwock"
Otwock , 05-40, Poland More Info
Marta Jackiewicz-Papierowska
Contact
+48 22 710 30 25
[email protected]
Cezary Szczylik
Principal Investigator
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy
Warsaw , 02-78, Poland More Info
Elżbieta Sierkowska
Contact
+48 509761001
[email protected]
Zbigniew Nowecki
Principal Investigator
Wojewódzka Przychodnia Onkologiczna, Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Łódź , 91-21, Poland More Info
Katarzyna Majda
Contact
48 507602151
[email protected]
Monika Kukulska
Principal Investigator
Instytut Centrum Zdrowia Matki Polki
Łódź , 93-33, Poland More Info
Marta Grubiak
Contact
48 792206646
[email protected]
Ewa Kalinka
Principal Investigator
A Coruña University Hospital
A Coruña , , Spain More Info
Belén López
Contact
34 981178000
[email protected]
Silvia Antolín Novoa
Principal Investigator
Hospital Universitari Dexeus
Barcelona , 08028, Spain More Info
Laura Raventos Soler
Contact
34 935460143
[email protected]
Laia Garrigos
Principal Investigator
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
Barcelona , 08035, Spain More Info
Cristina Saura
Contact
34-93-489-42-57
[email protected]
Meritxell Bellet Ezquerra
Principal Investigator
Institut Catala d'Oncologia (ICO)
Barcelona , 08908, Spain More Info
Leila Moreno Llorens
Contact
34-93.260.72.83
[email protected]
Ariadna Iserte
Contact
34-93-260-72-83
[email protected]
Juan Miguel Gil Gil
Principal Investigator
Hospital Universitari Arnau de Vilanova de Lleida
Lleida , 25198, Spain More Info
David Martinez
Contact
34 973003754
[email protected]
Serafin Morales Murillo
Principal Investigator
Hospital Ruber Internacional
Madrid , 28034, Spain More Info
Pilar Chaparro
Contact
34-91-387-50-90
[email protected]
Javier Cortes
Principal Investigator
Hospital Universitario 12 de Octubre (H12O)
Madrid , 28041, Spain More Info
Sara Murillo
Contact
34 91 390 86 26
[email protected]
Pablo Tolosa
Principal Investigator
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain More Info
Marta Garcia
Contact
34-91-756-79-84
[email protected]
Beatriz Rojas Garcia
Principal Investigator
Hospital Clínico Universitario de Valencia (CHUV)
Valencia , 46010, Spain More Info
Silvia Coret
Contact
34-630 50 68 88
[email protected]
Begoña Bermejo De Las Heras
Principal Investigator
Municipal Institution "Dnipropetrovsk City Multi-field Clinical Hospital #4", Dnepropetrovsk state m
Dnepropetrovsk , 49000, Ukraine More Info
Nataliia Urzhumova
Contact
38 097 322 27 44
[email protected]
Igor Bondarenko
Principal Investigator
State institution "V.T. Zaycev Institute of general and urgent surgery of National academy medical sciences of Ukraine"
Kharkiv , 61103, Ukraine More Info
Dmytro Piliuhin
Contact
38 050 979 98 84
[email protected]
Oleksandr Dudnichenko
Principal Investigator
Khmelnytsky Regional Antitumor Center, Department of Breast, Skin, Soft Tissues and Bones Tumorsa
Khmelnytskyi , 29000, Ukraine More Info
Ganna Drobner
Contact
'095 610 80 00
[email protected]
Igor Drobner
Principal Investigator
Kyiv City Clinical Oncology Center
Kyiv , 03115, Ukraine More Info
Natalia Voitko
Contact
38 0503818536
[email protected]
Natalia Voitko
Principal Investigator
Odessa Regional Oncological Dispensary
Odessa , 65000, Ukraine More Info
Serhii Brovchenko
Contact
38 0504406793
[email protected]
Dmytro Trukhin
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

210

Study ID:

NCT04869943

Recruitment Status:

Recruiting

Sponsor:


Veru Inc.

How clear is this clinincal trial information?

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