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Myeloid Inhibition + Radiation for Breast Cancer
Los Angeles, CA
Phase 2
Waitlist Available
Led By Stephen L Shiao, MD, PhD
Research Sponsored by Stephen Shiao
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically-confirmed TNBC (defined as ER <1%, PR<1%, her-2-neu 0-1+ by IHC or FISH-negative)
Patients diagnosed with high-risk triple negative breast cancer (TNBC)
Must not have
Has a known history of active TB (Bacillus Tuberculosis)
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., > Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from c1d1 until death, up to 3 years after end of study treatment.
Awards & highlights
No Placebo-Only Group
Summary
This trial studies a combination treatment to see if it helps people with TNBC (breast cancer) get better. It looks at how well it works, safety and other outcomes.
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Who is the study for?
This trial is for women over 18 with high-risk triple negative breast cancer (TNBC) who haven't had certain treatments recently. They must have low immune cell counts in their tumors, be able to provide tissue samples, and show good organ function. Pregnant or breastfeeding women can't join, nor can those with recent other cancers, serious infections like HIV or hepatitis, autoimmune diseases treated within the last two years, or brain metastases.Check my eligibility
What is being tested?
The study tests pembrolizumab combined with radiation therapy and CSF-1R inhibition (Axatilimab) on TNBC patients. It aims to see if this combo increases the rate of complete disappearance of cancer from the breast and lymph nodes after standard treatment. Other goals include checking safety and how long patients live without cancer progression.See study design
What are the potential side effects?
Possible side effects may include skin reactions from radiation, immune-related issues such as inflammation in organs due to pembrolizumab, infusion reactions from Axatilimab, fatigue, changes in blood cells leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is triple-negative.
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I have been diagnosed with high-risk triple negative breast cancer.
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I am a woman aged 18 or older.
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My organs are functioning well.
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My cancer has spread to my lymph nodes.
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I am fully active or restricted in physically strenuous activity but can do light work.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active tuberculosis infection.
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I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.
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I have received an organ or tissue transplant from another person.
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My cancer has spread to other parts of my body.
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I had radiotherapy less than 2 weeks before starting the study treatment.
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I have been diagnosed with HIV.
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I have an active Hepatitis B or C infection.
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I am currently being treated for an infection.
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I have or had lung inflammation or disease needing steroid treatment.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from c1d1 until death, up to 3 years after end of study treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from c1d1 until death, up to 3 years after end of study treatment.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pathological complete response (pCR) rate.
Secondary study objectives
Change in tumor-infiltrating lymphocytes (TILs) from biopsies.
Event-free survival (EFS).
Node clearance.
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab with Radiation Therapy and AxatilimabExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2630
Radiation Therapy
2004
Completed Phase 3
~7740
Axatilimab
2017
Completed Phase 1
~50
Find a Location
Closest Location:Cedars-Sinai Medical Center· Los Angeles, CA
Who is running the clinical trial?
Stephen ShiaoLead Sponsor
1 Previous Clinical Trials
66 Total Patients Enrolled
1 Trials studying Breast Cancer
66 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
4,088 Previous Clinical Trials
5,224,240 Total Patients Enrolled
63 Trials studying Breast Cancer
8,074 Patients Enrolled for Breast Cancer
Incyte CorporationIndustry Sponsor
406 Previous Clinical Trials
66,721 Total Patients Enrolled
9 Trials studying Breast Cancer
632 Patients Enrolled for Breast Cancer
Stephen L Shiao, MD, PhDPrincipal InvestigatorCSMC