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Cryoablation + Immunotherapy for Early Stage Breast Cancer

N/A
Waitlist Available
Led By Elizabeth Comen, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Operable tumor measuring ≥1.5 cm in maximal diameter
The tumor should be more than 5 mm from the skin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after ipilimumab/nivolumab administration.
Awards & highlights

Study Summary

This trial is testing whether two cancer treatments, cryoablation and immune therapy, are safe to use together in women with early stage breast cancer.

Who is the study for?
This trial is for women over 18 with early stage breast cancer that hasn't spread far, has a tumor at least 1.5 cm wide and not too close to the skin. Participants must be able to follow the study schedule, not have certain diseases like HIV or hepatitis, and can't be pregnant or breastfeeding. They should also agree to use contraception.Check my eligibility
What is being tested?
The study tests combining cryoablation (freezing of the tumor) with immune therapies Ipilimumab and Nivolumab before surgery in patients with operable breast cancer. It aims to assess how safe this combination is as a pre-operative treatment.See study design
What are the potential side effects?
Possible side effects include typical reactions from immune therapy such as fatigue, diarrhea, skin issues, hormonal gland problems (like thyroid), liver inflammation, and potential autoimmune reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is larger than 1.5 cm and can be surgically removed.
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My tumor is located more than 5 mm away from the skin.
Select...
My cancer has not spread to distant parts of my body.
Select...
I am scheduled for breast surgery.
Select...
My tumor can be treated with freezing as decided by a radiologist.
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I am fully active or can carry out light work.
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My breast cancer has been confirmed as invasive adenocarcinoma by a pathology test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after ipilimumab/nivolumab administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after ipilimumab/nivolumab administration. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of adverse events

Side effects data

From 2022 Phase 2 trial • 30 Patients • NCT04118166
50%
Other, Disease Progression (death)
30%
Fatigue
23%
Cough
17%
Constipation
17%
Nausea
17%
Pruritis
13%
Anemia
13%
Hypothyroidism
13%
Abdominal pain
13%
Fever
13%
Weight loss
13%
Rash
10%
Productive cough
10%
Dyspnea
10%
Hyperthyroidism
10%
Diarrhea
10%
Other, Decreased appetite
7%
Abdominal bloating
7%
Headache
7%
Elevated ALT
7%
Elevated AST
7%
Intermittent heart palpitations
7%
Tachycardia
7%
Dry mouth
7%
Intermittent nausea
7%
Hyponatremia
7%
Other, Pain to right chest wall at recent site of cryo
7%
Wheezing
3%
Lower back throbbing pain
3%
Right apical pneumothorax
3%
Arthralgias
3%
Peripheral sensory neuropathy
3%
Intermittent brief blurry vision
3%
Other, Corneal abrasion
3%
Right pneumothorax
3%
Pain
3%
Muscle and joint aches
3%
Other, Infectious diarrhea
3%
Dizziness
3%
Other, Motor deficit, left side
3%
Pneumothorax
3%
Other, Motor deficit, right side
3%
Gum infection
3%
Other, Intermittent left sciatic pain
3%
Nasal congestion
3%
UTI
3%
Arthritis
3%
Chest wall pain
3%
Right shoulder pain (Pain in extremity)
3%
Worsening anxiety
3%
Hiccups
3%
Confusion
3%
Anxiety
3%
Insomnia
3%
Other, Intermittent bilateral hand numbness
3%
Right neck pain
3%
Other, Lack of appetite
3%
Pneumonitis
3%
Pleural effusion
3%
Intermittent abdominal bloating
3%
L eye redness
3%
Right pleural effusion
3%
L eye pain
3%
Other, Neuropathic pain
3%
Intermittent chills followed by hot flashes
3%
Allergic reaction
3%
Muscle weakness
3%
Worsening left leg weakness
3%
Muscle weakness, left-sided
3%
Muscle weakness, right-sided
3%
Neuropathy under R axilla
3%
Other, Occasional twitching sensation to anterior chest wall
3%
Respiratory failure
3%
Worsening cough
3%
Shortness of breath with exertion
3%
Hoarse voice
3%
Chest Pain
3%
Keratitis
3%
Tension pneumothorax (requiring ICU stay)
3%
Depression
3%
Sore throat
3%
Cardiac arrest
3%
Adrenal insufficiency
3%
Blood bilirubin increased
3%
Alkaline phosphatase increased
3%
Hematuria
3%
Proteinuria
3%
Intermittent bronchopulmonary hemorrhage
3%
Shortness of breath
3%
Hypoxia
3%
Other, Deep vein thrombois (DVT) of catheter
3%
Atrial fibrillation
3%
Pericarditis
3%
Sinus tachycardia
3%
Other, Decreased pulse
3%
Ringing in the ears (tinnitus)
3%
Hypophysitis
3%
Dry eyes
3%
Flashing lights
3%
L eye burning sensation
3%
L eye blurred vision
3%
R eye blurred vision
3%
Increased abdominal pain
3%
Diarrhea (intermittent)
3%
Intermittent nausea/vomiting
3%
Vomiting
3%
Other, Mucositis
3%
Intermittent fever
3%
Low grade fever
3%
Flu-like symptoms
3%
Intermittent chest pain to R sternal border exacerbated with deep inhalation
3%
Intermittent fatigue
3%
Other, Presumed pneumonia
3%
Fall
3%
Creatinine increased
3%
Elevated TSH
3%
TSH increased
3%
Decreased WBC count
3%
Anorexia
3%
Other, Gluteal pain and swelling
3%
Other, Arm pain left
3%
Other, Muscle aches and fatigue associated with COVID vaccine
3%
Other, Right thigh pain
3%
Other, Soreness to right lateral ribs
3%
Other, Soreness at site of recent cryoablation (R lung)
3%
Other, Soreness right chest wall
3%
Other, Soreness to left side at site of recent cryoablation
3%
Other, Soreness, right shoulder
3%
Other, Pelvic bone pain
3%
Other, Intermittent peripheral edema
3%
Other, Weakness to left shoulder
3%
Intermittent hematuria
3%
Blood tinge sputum
3%
Intermittent cough
3%
Intermittent cough w/chest tightness
3%
Intermittent cough with Blood tinge sputum
3%
Dry cough
3%
Other, Hair thinning
3%
Other, Leg ulcer left
3%
Other, Molluscum contagiousum on left arm
3%
Pulmonary embolism
3%
Upper respiratory infection (COVID-19)
3%
Intermittent wheezing
3%
Other, Hemoptysis
3%
Dry skin
3%
Facial rash
3%
Maculo-papular rash
3%
Maculo-papular rash to bilateral arms
3%
Post-inflammatory hyperpigmentation on left breast
3%
Tinea
3%
Other, Burned hand
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ipilimumab/Nivolumab + Cryotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cryoablation and Immune TherapyExperimental Treatment3 Interventions
Patients will undergo breast biopsy with cryoablation 7-10 days prior to the planned surgery, and ipilimumab with nivolumab administration 1-5 days before cryoablation. All patients will undergo surgery at the pre-determined day defined at the initial surgical consultation. Women will receive ipilimumab and nivolumab 1-5 days prior to US or MRI-guided core biopsy and cryoablation date. Intravenous ipilimumab will be administered as a single 1 mg/kg dose to be infused intravenously over 90 minutes. Intravenous nivolumab will be administered as a single 3 mg/kg dose to be infused intravenously over 60 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoablation
2016
Completed Phase 2
~1040
Ipilimumab
2014
Completed Phase 3
~2610
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,941 Previous Clinical Trials
588,911 Total Patients Enrolled
202 Trials studying Breast Cancer
80,968 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,831 Total Patients Enrolled
50 Trials studying Breast Cancer
8,260 Patients Enrolled for Breast Cancer
Elizabeth Comen, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Cryoablation Clinical Trial Eligibility Overview. Trial Name: NCT02833233 — N/A
Breast Cancer Research Study Groups: Cryoablation and Immune Therapy
Breast Cancer Clinical Trial 2023: Cryoablation Highlights & Side Effects. Trial Name: NCT02833233 — N/A
Cryoablation 2023 Treatment Timeline for Medical Study. Trial Name: NCT02833233 — N/A
~1 spots leftby Jun 2025
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