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Selective Androgen Receptor Modulator
Enobosarm Monotherapy for Breast Cancer (ARTEST Trial)
Phase 3
Waitlist Available
Research Sponsored by Veru Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 180
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new drug to see if it can improve survival in patients with metastatic breast cancer.
Who is the study for?
This trial is for men and women over 18 with AR+/ER+/HER2- metastatic breast cancer who've had at least two prior treatments, including an AI and fulvestrant with a CDK 4/6 inhibitor. Participants must have measurable disease, respond well to past treatments, and not be pregnant or planning pregnancy. Men must use contraception; women must be non-childbearing or agree to contraception.
What is being tested?
The trial tests the effectiveness of Enobosarm alone in treating specific metastatic breast cancer by monitoring how long patients live without their disease getting worse on scans. It's for those whose tumors are positive for certain receptors and who've previously responded to treatment.
What are the potential side effects?
While the side effects of Enobosarm aren't detailed here, common ones may include fatigue, nausea, changes in liver function tests, hormonal imbalances like testosterone increase or decrease which could affect mood or libido.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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).
Secondary study objectives
Objective Response Rate (ORR)
Side effects data
From 2022 Phase 2 trial • 18 Patients • NCT0297176172%
10016256-Fatigue
67%
10020772-Hypertension
50%
10019211-Headache
44%
10012727-Diarrhea
39%
10013963-Dyspnea
33%
10028813-Nausea
33%
progressive disease
33%
10047700-Vomiting
33%
10003988-Back pain
28%
10040752-Sinus tachycardia
28%
10021038-Hyponatremia
28%
10010774-Constipation
28%
10011224-Cough
28%
10022437-Insomnia
28%
10021097-Hypotension
28%
10002272-Anemia
28%
10020943-Hypoalbuminemia
22%
10001551-Alanine aminotransferase increased
22%
10003481-Aspartate aminotransferase increased
22%
10013573-Dizziness
22%
10002855-Anxiety
22%
10037032-Proteinuria
22%
10037087-Pruritus
22%
10028411-Myalgia
22%
10011914-Death NOS
22%
10050068-Edema limbs
22%
10062501-Non-cardiac chest pain
22%
10002646-Anorexia
22%
10028836-Neck pain
17%
10033371-Pain
17%
10000081-Abdominal pain
17%
10005265-Bloating
17%
10046300-Upper respiratory infection
17%
10046571-Urinary tract infection
17%
10021018-Hypokalemia
17%
10003239-Arthralgia
17%
10020642-Hyperhidrosis
17%
10041367-Sore throat
17%
10037847-Rash acneiform
17%
10047924-Wheezing
17%
10062466-Localized edema
11%
10013950-Dysphagia
11%
10008661-Cholesterol high
11%
10020949-Hypocalcemia
11%
10025233-Lymphedema
11%
10016173-Fall
11%
10047896-Weight gain
11%
10021005-Hypoglycemia
11%
10021143-Hypoxia
11%
10035598-Pleural effusion
11%
10037868-Rash maculo-papular
11%
10043565-Thromboembolic event
11%
10016766-Flatulence
11%
10016558-Fever
11%
10006002-Bone pain
11%
10033425-Pain in extremity
11%
10062572-Generalized muscle weakness
11%
10034620-Peripheral sensory neuropathy
11%
10012378-Depression
11%
10019450-Hematuria
11%
10036790-Productive cough
11%
hemoptysis
11%
10020407-Hot flashes
11%
10008531-Chills
11%
10016059-Facial pain
11%
10035528-Platelet count decreased
11%
10047900-Weight loss
11%
10044565-Tremor
6%
10020850-Hyperthyroidism
6%
10021114-Hypothyroidism
6%
10005886-Blurred vision
6%
eye discomfort
6%
10000060-Abdominal distension
6%
10013946-Dyspepsia
6%
10041569-Spinal fracture
6%
10021059-Hypophosphatemia
6%
10042554-Superficial thrombophlebitis
6%
10019279-Heart failure
6%
10012318-Dental caries
6%
10013781-Dry mouth
6%
10005047-Bladder infection
6%
10048038-Wound infection
6%
10021028-Hypomagnesemia
6%
INCREASED TRIGLYCERIDES
6%
LEFT SHOULDER PAIN
6%
RIGHT KNEE PAIN
6%
RIGHT THIGH PAIN
6%
increased muscle mass
6%
actinic keratosis, hyperplastic
6%
10013911-Dysgeusia
6%
10020765-Hypersomnia
6%
10024264-Lethargy
6%
10024419-Libido decreased
6%
10046904-Vaginal dryness
6%
10003504-Aspiration
6%
10028735-Nasal congestion
6%
OBSTRUCTIVE PNEUMONIA
6%
bilateral pneumonia
6%
10036402-Postnasal drip
6%
10013786-Dry skin
6%
10016825-Flushing
6%
bradypnea
6%
10017999-Gastrointestinal pain
6%
10001718-Allergic reaction
6%
stomach flu
6%
10011368-Creatinine increased
6%
10049182-White blood cell decreased
6%
GENERALIZED MSK PAIN
6%
RIGHT HIP PAIN
6%
muscle spasm
6%
10015090-Epistaxis
6%
rhonchi breath sounds
6%
10001760-Alopecia
6%
10054541-Periorbital edema
6%
stent placement
6%
muscle spasms (back)
6%
oliguria (mild)
6%
10006298-Breast pain
6%
10033474-Pain of skin
6%
10040741-Sinus bradycardia
6%
10014020-Ear pain
6%
10001367-Adrenal insufficiency
6%
10016750-Flank pain
6%
10001409-Adult respiratory distress syndrome
6%
10033557-Palpitations
6%
10015388-Esophageal pain
6%
discomfort
6%
10014222-Edema face
6%
10017577-Gait disturbance
6%
10022095-Injection site reaction
6%
DROWSINESS
6%
10020647-Hyperkalemia
6%
10025256-Lymphocyte count decreased
6%
10029366-Neutrophil count decreased
6%
10020639-Hyperglycemia
6%
10008496-Chest wall pain
6%
10046539-Urinary frequency
6%
10046593-Urinary urgency
6%
10061574-Urinary tract obstruction
6%
10063057-Cystitis noninfective
6%
10041349-Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Pembrolizumab, Enobosarm)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enobosarm Treatment GroupExperimental Treatment1 Intervention
Subjects 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.
Group II: Control Treatment GroupActive Control1 Intervention
Subjects 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enobosarm
2017
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Veru Inc.Lead Sponsor
10 Previous Clinical Trials
700 Total Patients Enrolled
BarnetteStudy ChairVeru Inc.
9 Previous Clinical Trials
676 Total Patients Enrolled