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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 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
2015
Completed Phase 3
~4010
Pembrolizumab
2017
Completed Phase 3
~3130
Breast Surgery
2021
Completed Phase 2
~60
Ipilimumab
2015
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationIndustry Sponsor
746 Previous Clinical Trials
857,909 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,624 Total Patients Enrolled
22 Trials studying Breast Cancer
6,184 Patients Enrolled for Breast Cancer
Susan G. Komen Breast Cancer FoundationOTHER
67 Previous Clinical Trials
220,278 Total Patients Enrolled
40 Trials studying Breast Cancer
214,995 Patients Enrolled for Breast Cancer
American Society of Clinical OncologyOTHER
37 Previous Clinical Trials
148,059 Total Patients Enrolled
8 Trials studying Breast Cancer
923 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,098,991 Total Patients Enrolled
50 Trials studying Breast Cancer
8,167 Patients Enrolled for Breast Cancer
Monica MitaLead Sponsor
2 Previous Clinical Trials
22 Total Patients Enrolled
2 Trials studying Breast Cancer
22 Patients Enrolled for Breast Cancer
Heather McArthurLead Sponsor
Memorial Sloan Kettering Cancer CenterOTHER
1,979 Previous Clinical Trials
599,758 Total Patients Enrolled
207 Trials studying Breast Cancer
82,883 Patients Enrolled for Breast Cancer
Monica Mita, MDPrincipal InvestigatorCedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
9 Previous Clinical Trials
419 Total Patients Enrolled
4 Trials studying Breast Cancer
52 Patients Enrolled for Breast Cancer
Heather McArthur, MDPrincipal InvestigatorUT Southwestern Medical Center
1 Previous Clinical Trials
138 Total Patients Enrolled
1 Trials studying Breast Cancer
138 Patients Enrolled for Breast Cancer

Media Library

Ipilimumab+Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03546686 — Phase 2
Breast Cancer Research Study Groups: Treatment Arm
Breast Cancer Clinical Trial 2023: Ipilimumab+Nivolumab Highlights & Side Effects. Trial Name: NCT03546686 — Phase 2
Ipilimumab+Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03546686 — Phase 2
~17 spots leftby Jun 2026
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