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Antiandrogen
Enzalutamide + Trastuzumab for Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The subject has AR+ breast cancer
The subject has an Eastern Cooperative Oncology Group performance (ECOG) status ≤ 1 at Screening and Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first dose of study drug to the data cut-off date of 28 february 2017; the median duration of treatment was 70 days, and the maximum was 660 days.
Awards & highlights
Study Summary
This trial will test whether combining two drugs, enzalutamide and trastuzumab, is more effective at treating HER2+ and AR+ breast cancer than either drug alone.
Who is the study for?
This trial is for individuals with advanced or metastatic breast cancer that tests positive for both HER2 and AR. Participants should have an ECOG performance status of ≤1, indicating they are relatively able to carry out daily activities, and must have previously received at least one line of anti-HER2 therapy. They cannot join if they've had recent severe illnesses, brain metastasis, seizures, major surgeries or certain cancer treatments within specific time frames.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: Enzalutamide and Trastuzumab in patients with a particular type of breast cancer (HER2+ AR+). The goal is to see how effective this drug duo is in treating those whose disease has spread beyond the initial site (metastasized) or cannot be surgically removed.See study design
What are the potential side effects?
Enzalutamide may cause fatigue, back pain, hot flushes, hypertension, dizziness or falls. Trastuzumab can lead to heart problems like congestive heart failure or reduced heart function; it might also cause infusion reactions such as fever and chills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is AR positive.
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I am fully active and can carry on all pre-disease activities without restriction.
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I have a breast cancer diagnosis confirmed with a specific tissue sample.
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My cancer has spread or cannot be cured with surgery or radiation.
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My breast cancer is confirmed to be HER2 positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of first dose of study drug to the data cut-off date of 28 february 2017; the median duration of treatment was 70 days, and the maximum was 660 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first dose of study drug to the data cut-off date of 28 february 2017; the median duration of treatment was 70 days, and the maximum was 660 days.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Benefit Rate (CBR)
Secondary outcome measures
Best Overall Response Rate
Duration of Response
Number of Participants With Adverse Events (AEs)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Enzalutamide + TrastuzumabExperimental Treatment2 Interventions
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Enzalutamide
2014
Completed Phase 4
~2760
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,959 Total Patients Enrolled
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.Industry Sponsor
21 Previous Clinical Trials
9,830 Total Patients Enrolled
1 Trials studying Breast Cancer
101 Patients Enrolled for Breast Cancer
Executive Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
25 Previous Clinical Trials
8,149 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is AR positive.You have a disease that can be measured or evaluated using a specific medical standard. Pleural effusions, ascites, or other fluid spaces are not considered evaluable diseases.I have not had a stroke, mini-stroke, or lost consciousness in the last year.I had a non-invasive cancer before, but it was successfully treated.I haven't had cancer treatment, except for anti-HER2 therapy, in the last 14 days.I am fully active and can carry on all pre-disease activities without restriction.I have a breast cancer diagnosis confirmed with a specific tissue sample.I do not have any severe illnesses that would prevent me from joining the study.I've been cancer-free for 5 years after treatment for a previous cancer.My cancer has spread or cannot be cured with surgery or radiation.I have or had brain metastasis or leptomeningeal disease.I've needed medical help for a low blood sugar episode while on diabetes treatment in the last year.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I have a history of seizures or conditions that could lead to seizures.I have recovered from side effects of my previous treatments.I've had radiation for bone metastases within the last 14 days and side effects are resolved.I have had cancer other than breast cancer.My breast cancer is confirmed to be HER2 positive.I have had treatment for advanced cancer and it didn't work or I had to stop due to side effects, except for heart issues.
Research Study Groups:
This trial has the following groups:- Group 1: Enzalutamide + Trastuzumab
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.
Enzalutamide: is it more harmful than helpful?
"Enzalutamide has yet to be proven effective, but it did receive a score of 2 due to the data collected thus far supporting its safety."
Answered by AI
How many people are currently signed up for this research project?
"This particular trial is no longer actively recruiting patients. The listing was created on 8/28/2014 and last updated on 10/23/2022. However, there are 2376 trials for erbb-2 receptor and 304 trials for Enzalutamide that are still looking for participants."
Answered by AI
Could you please list all the different sites where this clinical trial is taking place?
"This study is being conducted out of Site US10082 in Houston, Texas, Site US10070 in Boston, Massachusetts, and Site CA15001 in Quebec City, Canada as well as 21 other locations."
Answered by AI
Are new patients being accepted into this clinical trial at this time?
"As of right now, this trial is not currently looking for more patients. It was initially posted on 8/28/2014 and updated for the last time on 10/23/2022. However, there are 2376 trials actively admitting participants with erbb-2 receptor and 304 trials for Enzalutamide that are still recruiting patients."
Answered by AI
What are the main health concerns that Enzalutamide is used to address?
"Enzalutamide is commonly used to treat breast cancer. However, it can also be effective in other scenarios, such as when the risk of cancer recurrence is high or as a first line treatment."
Answered by AI
What is the existing research on Enzalutamide?
"Enzalutamide was first studied two decades ago at Ospedale di Circolo e Fondazione Macchi. 437 clinical trials have completed and there are currently 304 active studies being conducted, many of which taking place in Houston, Texas."
Answered by AI
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