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Myeloid Inhibition + Radiation for Breast Cancer

Q: To what capacity is the patient population involved in this research?

Affirmative. Clinicaltrials.gov showcases that this experiment commenced on September 28th 2023 and is actively enrolling participants at the present time, with 35 individuals required from a single site.

Q: Is there an ongoing recruitment of participants for this clinical trial?

Yes, the online registry of clinicaltrials.gov confirms that this medical experiment is actively recruiting individuals. This research project was publicized on September 28th 2023 and has since been amended; 35 patients must be enrolled from a single site.

Q: Does the FDA endorse Pembrolizumab in combination with Radiation Therapy and Axatilimab?

Power's team has determined that, given the Phase 2 status of this trial and its lack of efficacy data, Pembrolizumab with Radiation Therapy and Axatilimab is provisionally rated a 2 on our safety scale.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from c1d1 until death, up to 3 years after end of study treatment.

Awards & highlights

Study 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.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 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.

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.

Treatment Details

Study Objectives

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

Primary outcome measures

Pathological complete response (pCR) rate.

Secondary outcome measures

Change in tumor-infiltrating lymphocytes (TILs) from biopsies.

Event-free survival (EFS).

Node clearance.

+2 more

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

Radiation Therapy

2017

Completed Phase 3

~7250

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 6Eligibility criteria met

Find a Location

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

3,892 Previous Clinical Trials

5,061,111 Total Patients Enrolled

58 Trials studying Breast Cancer

7,463 Patients Enrolled for Breast Cancer

Incyte CorporationIndustry Sponsor

365 Previous Clinical Trials

55,260 Total Patients Enrolled

8 Trials studying Breast Cancer

612 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

To what capacity is the patient population involved in this research?

"Affirmative. Clinicaltrials.gov showcases that this experiment commenced on September 28th 2023 and is actively enrolling participants at the present time, with 35 individuals required from a single site."

Answered by AI

Is there an ongoing recruitment of participants for this clinical trial?

"Yes, the online registry of clinicaltrials.gov confirms that this medical experiment is actively recruiting individuals. This research project was publicized on September 28th 2023 and has since been amended; 35 patients must be enrolled from a single site."

Answered by AI

Does the FDA endorse Pembrolizumab in combination with Radiation Therapy and Axatilimab?

"Power's team has determined that, given the Phase 2 status of this trial and its lack of efficacy data, Pembrolizumab with Radiation Therapy and Axatilimab is provisionally rated a 2 on our safety scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

Stephen Shiao 2023. "Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05491226.

All > Radiotherapy