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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
Aged ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 180
Awards & highlights

ARTEST 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.Check my eligibility
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.See study design
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.

ARTEST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are 18 years old or older.
Select...
You are able to carry out daily activities without any help, or with a little bit of help.
Select...
You have received at least two types of treatment for advanced breast cancer, including a specific combination of medications.
Select...
You need to have a disease that can be measured using specific guidelines.
Select...
You have had a good response to certain treatments for advanced breast cancer and the disease did not get worse for at least 6 months.

ARTEST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Objective Response Rate (ORR)

Side effects data

From 2022 Phase 2 trial • 18 Patients • NCT02971761
72%
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)

ARTEST 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
640 Total Patients Enrolled
BarnetteStudy ChairVeru Inc.
9 Previous Clinical Trials
616 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Enobosarm is often used for what reason?

"Enobosarm is an effective therapy for postmenopause, advance directives, and 2-3 years of tamoxifen."

Answered by AI

Are there any available openings for new recruits in this research project?

"Yes, this trial is still open and recruiting patients according to the information on clinicaltrials.gov. The listing was created on 12th October 2021 and updated 14th October 2022."

Answered by AI

Could you explain the possible risks associated with taking Enobosarm?

"Enobosarm's safety is estimated to be a 3. This rating comes from the fact that Enobosarm is in Phase 3 trials, meaning there is both evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

Could I qualify to take part in this research?

"This clinical trial is recruiting 210 people, within the ages of 18 and 100 who have malignant neoplasms. It is required that patients also meet the following criteria: Age <55 years and surgical menopause with bilateral oophorectomy, For Female Subjects, Menopausal status, Be able to communicate effectively with the study personnel, Age ≥55 years and one year or more of amenorrhea, Aged ≥18 years."

Answered by AI

Does this Phase III study include patients that are middle-aged?

"The age limit for this particular trial is 18 to 100. However, there are 68 other trials that cater to patients under the age of 18 and 2356 clinical trials for individuals over 65 years old."

Answered by AI

In how many different hospitals is this research project being conducted?

"At the time of this writing, patients are being accepted at 38 different locations including Virginia Oncology Associates in Norfolk, Virginia, Tidelands Health in Murrells Inlet, South carolina, and Cleveland Clinic Taussig Cancer Institute in Cleveland, Ohio."

Answered by AI

Is Enobosarm a new medication or has it been studied before?

"As of now, there are 61 different clinical trials researching Enobosarm. Out of those, 23 are in Phase 3. Even though a large number of the trials for Enobosarm originate in Pisa, PI, there are 7747 total locations running these studies."

Answered by AI

What is the total number of patients being treated in this clinical trial?

"210 patients that meet the study's requirements are necessary to begin. Veru Inc., the sponsor of this trial, will be running it from Virginia Oncology Associates and Tidelands Health."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer
2021. "Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04869943.
~15 spots leftby Apr 2025
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