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Checkpoint Inhibitor

Radiation + Pembrolizumab for Advanced Breast Cancer

Phase 2

Recruiting

Led By Elizabeth Riley, MD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease stage: unresectable or metastatic stage IV breast cancer.

Measurable disease, defined as at least 1 visceral or nodal/soft tissue breast cancer lesion that can be accurately and serially measured in at least 1 dimension and for which the longest diameter is ≥ 10 mm as measured by Computer Tomography scan or Magnetic Resonance Imaging. Lymph nodes must measure ≥ 15 mm in their short axis to be considered measurable by Computer Tomography scan or Magnetic Resonance Imaging or Positron Emission Tomography-CT.

Must not have

Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment or 4 months after the last dose of pembrolizumab.

Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment or 4 months after the last dose of pembrolizumab.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.0 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to see if a combination of two cancer treatments is effective and safe in treating breast cancer that has progressed after two other treatments.

Who is the study for?

This trial is for women over 18 with stage IV breast cancer that's spread and can't be removed by surgery. They must have tried two previous treatments, including a taxane and specific therapies based on their cancer type. Good organ function and no active brain metastases or immune diseases are required. Women must not be pregnant, breastfeeding, or planning pregnancy soon.

What is being tested?

The study tests combining stereotactic body radiation therapy (SBRT) with pembrolizumab in patients whose disease progressed after standard treatments. It's an open-label phase 2 trial where all participants receive the same experimental treatment to assess its effectiveness and safety.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects like inflammation of organs, infusion reactions, fatigue, skin rash, digestive issues, liver problems, hormone gland changes (like thyroid), and could worsen pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer cannot be surgically removed or has spread to other parts of my body.

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I have a breast cancer lesion or lymph node that can be measured and is large enough according to scans.

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I have had trastuzumab and Ado-trastuzumab TDM1 therapy for my HER2 positive breast cancer.

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I have had two previous cancer treatments, one of which included a taxane.

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I have triple negative breast cancer and have undergone two chemotherapy treatments for it.

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I can care for myself and am up and about more than 50% of my waking hours.

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My breast cancer diagnosis was confirmed through tissue examination.

Exclusion Criteria

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

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I am not willing to use birth control during the study and for 4 months after.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I have been diagnosed with HIV.

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I have hepatitis B or C.

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I have an active tuberculosis infection.

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I have had pneumonitis treated with steroids or have it now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.0 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.0 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.0 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure

Secondary study objectives

Measures-Best Overall Response Rate

Measures-Incidence of treatment-emergent and treatment-related adverse events

Measures-Progression-free Survival

Awards & 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: Palliative Radiation in Combination with PembrolizumabExperimental Treatment1 Intervention

Stereotactic radiation therapy will be delivered using either linac-based SBRT using 10x flattening filter-free (FFF) photons or Cyberknife Pencil Beam Technology utilizing 6X photons. Treatment will be delivered in 1-5 fractions. Fractionation and total dose (1500 - 3000 cGy) will depend on the site of disease, previous radiation treatment, and patient symptomatology. Pembrolizumab is supplied as pembrolizumab 100 mg/4 mL vials (25 mg/mL) solution for intravenous infusion. Pembrolizumab at a dose of 200 mg will be administered intravenously every 3 weeks (± 3 days).

0 / 13Eligibility criteria met