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Androgen Receptor Blockade
Triple Therapy for Breast Cancer
Phase 2
Waitlist Available
Led By David B. Page, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0-1
Metastatic or locally advanced unresectable HER2-negative breast cancer (by NCCN criteria)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new treatment for metastatic cancer that could be more effective and have fewer side effects than current chemotherapy.
Who is the study for?
This trial is for women over 18 with HER2-negative breast cancer that's advanced and can't be removed by surgery or has spread (metastatic). They should have had no more than one chemotherapy treatment in the non-curative setting, must not be breastfeeding, agree to birth control measures, and have good blood and liver function. Men, pregnant women, those with certain medical conditions or a history of other cancers within the last three years are excluded.Check my eligibility
What is being tested?
The study tests combining Nivolumab and Ipilimumab (immune checkpoint inhibitors) with Bicalutamide (androgen receptor blocker) as an alternative to chemotherapy for metastatic breast cancer. It aims to see if this combination improves response without using chemo initially or delaying its need.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs, skin rash, hormone imbalances due to blocking the androgen receptor, fatigue, possible infusion-related reactions from the drugs administered intravenously, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My breast cancer cannot be removed by surgery and is not HER2 positive.
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I have signed the consent form for this study.
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My blood and liver tests are within the required ranges.
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I am a woman aged 18 or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
iRECIST Clinical Benefit Rate (the number of patients with objective response or ongoing stable disease at week 24 using iRECIST guidelines)
Secondary outcome measures
Assess best overall objective response rate (proportion of patients who achieve a complete or partial response)
Duration of progression free survival
Overall survival rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab, Ipilimumab, and bicalutamideExperimental Treatment3 Interventions
Participants will receive nivolumab plus ipilimumab combination therapy. Participants should receive nivolumab at a dose of 240 milligrams (mg) fixed dose as a 30-minute intravenous (IV) infusion prepared in 50 milliliter (ml) normal saline (NS) every 2 weeks until progression. Participants should receive ipilimumab at a dose of 1 mg/kilogram as a 30-minute IV infusion prepared in 50 ml NS every 6 weeks. All subjects will take bicalutamide 150mg (3 x 50mg tablets) daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Bicalutamide
2003
Completed Phase 3
~5330
Find a Location
Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,505 Total Patients Enrolled
6 Trials studying Breast Cancer
4,578 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,484 Total Patients Enrolled
50 Trials studying Breast Cancer
8,235 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterOTHER
1,933 Previous Clinical Trials
585,592 Total Patients Enrolled
202 Trials studying Breast Cancer
81,107 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease but it's under control or is one of the exceptions listed.I have lung disease that could affect my treatment's safety monitoring.You have hepatitis B or C that is currently active.I am fully active or can carry out light work.My breast cancer cannot be removed by surgery and is not HER2 positive.I've had only one chemotherapy treatment for my cancer that wasn't meant to cure it.I have signed the consent form for this study.My brain cancer has been treated and stable for at least 2 weeks.My heart condition severely limits my physical activity.My side effects from previous cancer treatments, except for hair loss and tiredness, have mostly gone away.I have recovered from major surgery or a serious injury for at least 14 days.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I have had issues like acute diverticulitis or GI obstruction in the past.I haven't had specific immune treatments for my cancer in the last year.My triple negative breast cancer is androgen-receptor positive.I have been treated with medications that block male hormones.I am willing and able to follow the study's schedule and requirements.My blood and liver tests are within the required ranges.I agree to use birth control during and for 5 months after treatment.I haven't had active cancer in the last 3 years, except for certain skin cancers or cervical cancer in situ.My adrenal glands are not working properly and it's not under control.I am a woman aged 18 or older.You have been diagnosed with HIV or AIDS.You have a disease that can be measured using the RECIST1.1 criteria.I am willing to provide a new or recent tumor sample for the study.Women who could become pregnant must have a negative pregnancy test within a day before starting the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab, Ipilimumab, and bicalutamide
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.
Is this experimental protocol a pioneering venture?
"Since the year 2000, research has been conducted on bicalutamide. AstraZeneca launched its foundational study in that same year and after 600 participants were evaluated, it was approved for Phase 3 drug testing. Currently, 797 clinical trials are active globally over a span of 51 nations across 2492 cities."
Answered by AI
To what ailments is Bicalutamide commonly prescribed?
"Bicalutamide is a widely used treatment for anti-angiogenic therapies and other maladies such as unresectable melanoma, squamous cell carcinoma, and various forms of neoplasms."
Answered by AI
Is registration open for this research project?
"According to the clinicaltrials.gov database, this trial is currently in search of participants and was first advertised on April 3rd 2019, with an update occurring on January 31st 2022."
Answered by AI
Could you provide a synopsis of the previous research conducted on Bicalutamide?
"Presently, there are 797 clinical trials involving Bicalutamide with 100 of them being in the advanced Phase 3. Although most studies occur in Pittsburgh, Pennsylvania; a total of 46392 medical sites across the globe operate these tests."
Answered by AI
What potential harms are associated with the utilization of Bicalutamide?
"Due to its Phase 2 status, where there is evidence of safety but no proof yet for efficacy, our team at Power assessed bicalutamide's safety rating as a 2 on the 1-3 scale."
Answered by AI
What is the current enrollment size for this clinical trial?
"That is correct. According to the information located on clinicaltrials.gov, this medical study is actively recruiting subjects and was initially posted on April 3rd 2019 before being updated most recently in January of 2022. 138 participants are desired from one facility only."
Answered by AI
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