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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 a woman aged 18 or older.
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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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My cancer may or may not have spread to my lymph nodes.
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All areas of my breast cancer have been biopsied and are triple-negative.
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I am using birth control and my pregnancy test was negative.
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I have breast cancer in both breasts, and all tumors are triple-negative.
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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-Free Survival
Secondary outcome measures
Distant Disease-Free Survival
Invasive Disease-Free Survival
Overall Safety
+1 more

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
Pembrolizumab
2017
Completed Phase 2
~2010
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750
Breast Surgery
2021
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationIndustry Sponsor
716 Previous Clinical Trials
931,925 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,043 Previous Clinical Trials
1,053,470 Total Patients Enrolled
21 Trials studying Breast Cancer
6,182 Patients Enrolled for Breast Cancer
Susan G. Komen Breast Cancer FoundationOTHER
65 Previous Clinical Trials
217,108 Total Patients Enrolled
40 Trials studying Breast Cancer
214,992 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

Frequently Asked Questions

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

What is the present size of the patient cohort for this research study?

"This clinical trial is in need of 80 qualified participants. Patients may come from any number of designated sites, including Cedars Sinai Medical Center in Los Angeles and Providence Cancer Institute in Portland."

Answered by AI

What other research efforts have been undertaken concerning Nivolumab?

"At the present moment, 765 medical trials are in progress for Nivolumab. Of those studies, 86 are currently at Phase 3 and span 42755 different locations; most of which can be found in Pittsburgh, Pennsylvania."

Answered by AI

For which illnesses is Nivolumab a prescribed treatment?

"Nivolumab is employed in the treatment of a variety of diseases and conditions, including but not limited to malignant neoplasms, unresectable melanoma and squamous cell carcinoma. It can also be used as an adjunct therapy following anti-angiogenic treatments."

Answered by AI

Is recruitment still open for this research protocol?

"Affirmative. Information on clinicaltrials.gov verifies that this research endeavour, initially published on November 12th 2019, is actively seeking participants. Approximately 80 individuals need to be recruited from 3 separate facilities."

Answered by AI

Has Nivolumab received regulatory authorization from the Federal Drug Administration?

"Nivolumab has been evaluated in Phase 2 trials and, based on our team's assessment, it was deemed to possess a safety rating of 2. This signifies that the drug had some data supporting its safety but not confirming efficacy."

Answered by AI
~3 spots leftby Jun 2024