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Hormone Therapy
Pembrolizumab + Enobosarm for Breast Cancer
Phase 2
Waitlist Available
Led By Yuan Yuan
Research Sponsored by City of Hope Medical Center
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 up to 1 year
Awards & highlights
Study Summary
This trial is testing pembrolizumab and enobosarm to see if they're effective in treating patients with androgen receptor positive triple negative breast cancer.
Who is the study for?
This trial is for adults with a specific breast cancer type that has spread (metastatic triple negative, androgen receptor positive). Participants must have proper liver, kidney, and blood function, not be pregnant or breastfeeding, use effective birth control if of childbearing potential, and cannot have had certain recent treatments or uncontrolled diseases.Check my eligibility
What is being tested?
The study tests pembrolizumab (an immune system booster) combined with enobosarm (a hormone therapy blocking tumor growth by targeting androgen) to see if they work better together against this breast cancer compared to pembrolizumab alone.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells in addition to cancer cells. This can lead to inflammation in various organs. Hormone therapy may cause changes in mood or libido, muscle pain or weakness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate (Complete Response or Partial Response)
Secondary outcome measures
Clinical Benefit Rate
Overall Survival
Progression-free Survival
Other outcome measures
Androgen receptor expression profile
Micro ribonucleic acid (miRNA)/messenger ribonucleic acid (mRNA) profiling
Number of circulating tumor cells and quantitation of circulating tumor deoxyribonucleic acid (ctDNA)
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, enobosarm)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enobosarm
2017
Completed Phase 2
~20
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,442 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,135 Total Patients Enrolled
1 Trials studying Androgen Receptor Positive
18 Patients Enrolled for Androgen Receptor Positive
Yuan YuanPrincipal InvestigatorCity of Hope Medical Center
6 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver enzymes (AST and ALT) should be within a certain range, unless you have liver metastases, in which case they can be slightly higher.You have received certain types of immune system-targeted treatments.You have been treated with specific medications that target the androgen receptor.You have taken hormone replacement therapies within 14 days before starting the study treatment.Women who can have babies need to have a negative pregnancy test before starting the treatment. If the urine test is positive or uncertain, a blood test will be needed.Your kidney function needs to be normal or near normal, based on a blood test and a calculation of how well your kidneys are working.You are taking long-term steroid medication or other drugs that lower your immune system.You have breast cancer that has spread to other parts of the body and is negative for three specific receptors.Your albumin level in your blood should be at least 2.5 mg/dL within 14 days before starting the treatment.You have a history of HIV, hepatitis B, or hepatitis C.You have been diagnosed with triple-negative breast cancer using specific guidelines from the American Society of Clinical Oncology and the College of American Pathologists.Your breast cancer does not have certain proteins (ER, PR, HER2) when tested using specific methods.You have unstable or untreated cancer that has spread to the brain or surrounding tissues.Your hemoglobin level is at least 9 g/dL (or 5.6 mmol/L) without needing a blood transfusion or erythropoietin (EPO) within the past 7 days.You had a bad allergic reaction to another type of medication like the one being studied.Any side effects from your previous treatment must have improved to a mild level, except for tingling in your nerves or hair loss.You have a history of lung inflammation that needed treatment with steroids, or you currently have lung inflammation.Your white blood cell count is at least 1500 per cubic millimeter.You are currently taking bisphosphonate or denosumab and have high levels of calcium in your blood.You are willing to give a sample of a recent tumor biopsy taken within 42 days before starting the trial.You must have a good ability to perform daily activities and take care of yourself.You are expected to live for more than 3 months.You have a disease that can be measured using specific criteria called RECIST version 1.1.You have a positive test for androgen receptor.You have a current or recent severe stomach or intestine problem that could cause a hole in the bowel.You have taken certain hormones or medications that affect testosterone levels within the last 30 days.You have an ongoing autoimmune disease that needed strong medication in the last 2 years.Your platelet count needs to be at least 100,000 per cubic millimeter within 14 days before starting the treatment.You have been diagnosed with or treated for cancer, except for breast cancer or non-melanoma skin cancer, in the past two years.You cannot swallow pills.Your bilirubin levels in the blood should not be higher than a certain limit before starting the treatment.You have cancer that has spread to your brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, enobosarm)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the required qualifications able to participate in this trial currently?
"Recruitment for this study has concluded. However, there are presently 2440 clinical trials actively searching for patients with malignant neoplasm of breast and 1002 trials for Pembrolizumab actively enrolling participants."
Answered by AI
How many individuals are enrolled in this research project?
"Unfortunately, this clinical trial is no longer active. Although it was originally posted on June 1st, 2017, the most recent update was on June 8th, 2022. However, there are presently 2440 studies actively enrolling patients with malignant neoplasm of breast and 1002 studies for Pembrolizumab actively looking for participants."
Answered by AI
Is this research being conducted in multiple locations within the city?
"This study is being conducted at seven different sites, four of which are located in South Pasadena, Mission Hills and West Covina. The other locations for this research are situated in other cities. To cut down on commute times, patients are encouraged to pick the clinical trial site nearest to them."
Answered by AI
Does Pembrolizumab have the green light from the FDA?
"Pembrolizumab falls into Phase 2 of testing, so there is some data supporting its safety but none yet for efficacy. Therefore, our team at Power estimates the safety to be a 2."
Answered by AI
What other scientific papers mention Pembrolizumab?
"At the moment, there are 1002 studies underway that focus on pembrolizumab. 124 of those trials are classified as Phase 3 studies. Although a majority of the trials for pembrolizumab are based in Houston, Texas, there are 36128 locations worldwide where this treatment is being studied."
Answered by AI
What is the primary goal of this experiment?
"The study's primary outcome, which will be monitored over the course of 3 years, is measuring dose-limiting toxicities. Additionally, the research team wants to assess overall survival rates, clinical benefit rates, and other data points over that same time frame."
Answered by AI
What are the most common reasons that Pembrolizumab is given to patients?
"Pembrolizumab is an effective treatment for malignant neoplasms, unresectable melanoma, and patients with microsatellite instability high."
Answered by AI
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