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Checkpoint Inhibitor

Immune Therapy + Cryoablation for Breast Cancer

Phase 2

Recruiting

Led By Monica Mita, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

No indication of distant metastases

Total mastectomy or lumpectomy planned

Must not have

Chronic use of immunosuppressants and/or systemic corticosteroids

Has a known history of HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that may improve Event Free Survival rates for women with a certain type of breast cancer.

Who is the study for?

This trial is for women over 18 with triple-negative breast cancer that's operable and hasn't spread far. They should have finished certain chemo, be able to undergo surgery, and not have other serious health issues or recent cancers. Participants must use birth control if needed and pass specific blood tests.

What is being tested?

The study is testing the combination of a freezing technique called cryoablation with drugs Pembrolizumab, Ipilimumab, or Nivolumab before surgery. The goal is to see how this affects survival without cancer worsening within three years after treatment.

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation in various organs, skin problems, hormone gland issues (like thyroid), fatigue, flu-like symptoms, and potential complications from the cryoablation procedure.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has not spread to distant parts of my body.

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I am scheduled for a total mastectomy or lumpectomy.

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I am fully active or can carry out light work.

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My cancer has been confirmed as invasive by a pathology report.

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My cancer is triple-negative based on biopsy results.

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My tumor can be surgically removed and is at least 1.0 cm big.

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I have been diagnosed with invasive breast cancer.

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My tumor can be treated with freezing as decided by a radiologist.

Exclusion Criteria

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

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I regularly take medication to suppress my immune system.

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I have a known history of HIV.

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I have active hepatitis B or C.

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I haven't had cancer in the last 5 years, except for certain skin, cervical, or ovarian cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Event-Free Survival

Secondary study objectives

Distant Disease-Free Survival

Invasive Disease-Free Survival

Overall Safety

+1 more

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: Treatment ArmExperimental Treatment5 Interventions

Pembrolizumab + Core Biopsy/Cryoablation + Breast Surgery +Post Surgery pembrolizumab OR Ipilimumab and Nivolumab + Core Biopsy/Cryoablation + Breast Surgery +Post Surgery Nivolumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

Pembrolizumab

2017

Completed Phase 3

~2810