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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 predose on day 1 (baseline), week 9 and week 17
Awards & highlights
Summary
This trial will test if a new medication, enzalutamide, is safe and effective for treating patients with advanced breast cancer who express the androgen receptor, but not the estrogen or progesterone receptor, and are not Her2 amplified.
Who is the study for?
This trial is for women aged 18 or older with advanced breast cancer that tests positive for androgen receptors but negative for estrogen/progesterone receptors, without Her2 amplification. Participants must have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory. They cannot join if they've had certain treatments recently, another invasive cancer within 5 years, major surgery within 4 weeks, seizures, brain metastasis, significant heart disease, abnormal blood counts or creatinine levels.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of Enzalutamide in treating advanced triple-negative breast cancer (TNBC) that expresses the androgen receptor (AR+). It aims to see how well patients respond to this medication when other common hormone receptors are not present.See study design
What are the potential side effects?
Potential side effects of Enzalutamide may include fatigue, back pain, hot flushes, headache, high blood pressure, dizziness or spinning sensation; however specific side effects will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose on day 1 (baseline), week 9 and week 17
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 (baseline), week 9 and week 17
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population
Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population
Secondary outcome measures
Percentage of Participants With Best Objective Response: Evaluable Population
Percentage of Participants With Best Objective Response: ITT Population
Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population
+3 moreOther outcome measures
Number of Participants With Change From Baseline in Laboratory Parameters Grades by 2 or More Grades
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Number of Participants With Grade 3 or Higher Adverse Events
+3 moreSide effects data
From 2017 Phase 4 trial • 215 Patients • NCT0211658234%
Fatigue
25%
Decreased appetite
18%
Asthenia
17%
Back pain
16%
Arthralgia
15%
Nausea
13%
Bone pain
13%
Diarrhoea
13%
Constipation
12%
Pain in extremity
12%
Weight decreased
11%
Anaemia
11%
Musculoskeletal pain
9%
Hypertension
8%
Oedema peripheral
7%
Dizziness
7%
Haematuria
6%
Insomnia
6%
Hot flush
6%
Malignant neoplasm progression
6%
Muscular weakness
5%
General physical health deterioration
5%
Vomiting
5%
Dyspnoea
3%
Spinal cord compression
2%
Renal failure acute
2%
Pneumonia
2%
Pulmonary embolism
1%
Cardiac failure
1%
Pyrexia
1%
Urinary tract infection
1%
Lower respiratory tract infection
1%
Neutropenia
1%
Metastases to central nervous system
1%
Lung disorder
1%
Renal failure
1%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enzalutamide Total
Trial Design
1Treatment groups
Experimental Treatment
Group I: EnzalutamideExperimental Treatment1 Intervention
160 mg administered as four 40 mg soft gelatin capsules orally once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,595 Previous Clinical Trials
12,868,652 Total Patients Enrolled
114 Trials studying Breast Cancer
36,195 Patients Enrolled for Breast Cancer
Astellas Pharma IncIndustry Sponsor
694 Previous Clinical Trials
233,138 Total Patients Enrolled
7 Trials studying Breast Cancer
508 Patients Enrolled for Breast Cancer
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.Industry Sponsor
21 Previous Clinical Trials
9,816 Total Patients Enrolled
1 Trials studying Breast Cancer
101 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a stomach or intestine problem that makes it hard for your body to absorb medicine.You had another type of cancer within the last 5 years.You had radiation therapy within 7 days before the study starts.You have a history of seizures or any condition that makes you more likely to have a seizure.You need to have a sample of your tumor for testing, and it needs to show either measurable disease or nonmeasurable disease in the bones.You had a low blood sugar episode that needed medical help while taking insulin in the last year.You have advanced triple-negative breast cancer that is positive for androgen receptors.You are currently using hormone replacement therapy.Women who are 18 years old or olderYour blood counts are too low, including white blood cells, platelets, or hemoglobin.You have or had cancer that has spread to your brain.You have a serious heart condition.You are allergic to the main ingredient or any parts of the capsules, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.Your creatinine level is higher than it should be during the screening visit.If you have a serious health problem or infection, you cannot participate.You are able to perform daily activities without restrictions or with only slight restrictions.
Research Study Groups:
This trial has the following groups:- Group 1: Enzalutamide
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.
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