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Myeloid Inhibition + Radiation for Breast Cancer

Phase 2

Recruiting

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.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from c1d1 until death, up to 3 years after end of study treatment. for reporting.