← Back to Search

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.0 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

My breast cancer diagnosis was confirmed through tissue examination.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure

Secondary outcome measures

Measures-Best Overall Response Rate

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

Measures-Progression-free Survival

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

339 Previous Clinical Trials

76,665 Total Patients Enrolled

5 Trials studying Breast Cancer

325 Patients Enrolled for Breast Cancer

James Graham Brown Cancer CenterOTHER

43 Previous Clinical Trials

9,203 Total Patients Enrolled

3 Trials studying Breast Cancer

275 Patients Enrolled for Breast Cancer

Elizabeth Riley, MDPrincipal InvestigatorUL Health Brown Cancer Center Deputy Director, Health Affairs

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04990921 — Phase 2

Breast Cancer Research Study Groups: Palliative Radiation in Combination with Pembrolizumab

Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04990921 — Phase 2

Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04990921 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being monitored for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is still recruiting patients since its initial launch on September 2nd 2021 and last update of November 5th 2021. A total of 15 people need to be admitted at a single site."

Answered by AI

Has there been precedent established for the combination of Palliative Radiation and Pembrolizumab in clinical research?

"At the moment, 961 research projects are currently running that investigate Palliative Radiation and Pembrolizumab. Of these active clinical trials, 122 have entered Phase 3 of their investigation. Although Houston is the primary city for testing this treatment type, 35731 sites across the world are also conducting studies in support of it."

Answered by AI

Has the Federal Drug Administration sanctioned Palliative Radiation and Pembrolizumab?

"Our evaluation gave Palliative Radiation and Pembrolizumab a rating of 2 since this is being tested in Phase 2. This suggests that while there are some records attesting to the treatment's safety, no data has yet been collected on its efficacy."

Answered by AI

Is enlistment still available for this research endeavor?

"According to clinicaltrials.gov, this study is currently recruiting patients since it was first posted on September 2nd 2021 and subsequently modified on November 5th of the same year."

Answered by AI

What illnesses are typically managed with Palliative Radiation and Pembrolizumab?

"Palliative Radiation and Pembrolizumab are usually prescribed to treat cancerous growths. However, it has also been successful in treating certain cases of unresectable melanoma, microsatellite instability high levels, and disease progression after chemotherapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Palliative Radiation Combined With Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer

Elizabeth Riley 2021. "Study of Palliative Radiation Combined With Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04990921.

All > Breast Cancer Cincinnati