Trial Outcomes & Findings for A Study of Pre-Operative Treatment With Cryoablation and Immune Therapy in Early Stage Breast Cancer (NCT NCT02833233)
NCT ID: NCT02833233
Last Updated: 2024-10-23
Results Overview
Safety will be evaluated for all treated subjects using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
12 weeks after ipilimumab/nivolumab administration.
Results posted on
2024-10-23
Participant Flow
Participant milestones
| Measure |
Cryoablation and Immune Therapy
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.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Pre-Operative Treatment With Cryoablation and Immune Therapy in Early Stage Breast Cancer
Baseline characteristics by cohort
| Measure |
Cryoablation and Immune Therapy
n=5 Participants
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.
|
|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after ipilimumab/nivolumab administration.Safety will be evaluated for all treated subjects using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Outcome measures
| Measure |
Cryoablation and Immune Therapy
n=5 Participants
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.
|
|---|---|
|
Number of Participants Evaluated for Adverse Events
|
5 Participants
|
Adverse Events
Cryoablation and Immune Therapy
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cryoablation and Immune Therapy
n=5 participants at risk
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.
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|---|---|
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General disorders
Death NOS
|
20.0%
1/5 • 12 weeks
|
Other adverse events
| Measure |
Cryoablation and Immune Therapy
n=5 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
80.0%
4/5 • 12 weeks
|
|
Investigations
Alanine aminotransferase increased
|
60.0%
3/5 • 12 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
60.0%
3/5 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
60.0%
3/5 • 12 weeks
|
|
Investigations
Alkaline phosphatase increased
|
40.0%
2/5 • 12 weeks
|
|
General disorders
Fatigue
|
40.0%
2/5 • 12 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • 12 weeks
|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5 • 12 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
20.0%
1/5 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
20.0%
1/5 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • 12 weeks
|
|
Eye disorders
Dry eye
|
20.0%
1/5 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
1/5 • 12 weeks
|
|
Vascular disorders
Hot flashes
|
20.0%
1/5 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • 12 weeks
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • 12 weeks
|
|
General disorders
Pain
|
20.0%
1/5 • 12 weeks
|
|
Cardiac disorders
Palpitations
|
20.0%
1/5 • 12 weeks
|
|
Nervous system disorders
Paresthesia
|
20.0%
1/5 • 12 weeks
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • 12 weeks
|
|
Renal and urinary disorders
Urinary urgency
|
20.0%
1/5 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
20.0%
1/5 • 12 weeks
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • 12 weeks
|
Additional Information
Dr. Elizabeth Comen
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place