Trial Outcomes & Findings for Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer (NCT NCT03237572)
NCT ID: NCT03237572
Last Updated: 2026-02-09
Results Overview
How many of the immune cells inside a tumor are a specific type of "killer" T cell
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
baseline and week 4
Results posted on
2026-02-09
Participant Flow
Participant milestones
| Measure |
Arm A: 1st Dose of Pembrolizumab After HIFU
Pembrolizumab (200 mg) administered intravenously, days 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Pembrolizumab: Pembrolizumab (200 mg)
High-intensity focused ultrasound (HIFU): Ablation will target 50% of the tumor, up to 3 cubic centimeters
|
Arm B: 1st Dose of Pembrolizumab Before HIFU
Pembrolizumab (200 mg) intravenously, days 1, 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Pembrolizumab: Pembrolizumab (200 mg)
High-intensity focused ultrasound (HIFU): Ablation will target 50% of the tumor, up to 3 cubic centimeters
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A: 1st Dose of Pembrolizumab After HIFU
n=6 Participants
Pembrolizumab (200 mg) administered intravenously, days 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Pembrolizumab: Pembrolizumab (200 mg)
High-intensity focused ultrasound (HIFU): Ablation will target 50% of the tumor, up to 3 cubic centimeters
|
Arm B: 1st Dose of Pembrolizumab Before HIFU
n=7 Participants
Pembrolizumab (200 mg) intravenously, days 1, 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Pembrolizumab: Pembrolizumab (200 mg)
High-intensity focused ultrasound (HIFU): Ablation will target 50% of the tumor, up to 3 cubic centimeters
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Customized
|
47.7 years
STANDARD_DEVIATION 10.3 • n=41 Participants
|
57.9 years
STANDARD_DEVIATION 9.63 • n=1581 Participants
|
53.2 years
STANDARD_DEVIATION 10.9 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
12 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
7 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=41 Participants
|
7 participants
n=1581 Participants
|
13 participants
n=4626 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
|
1.2 units on a scale
n=41 Participants
|
1.3 units on a scale
n=1581 Participants
|
1.2 units on a scale
n=4626 Participants
|
PRIMARY outcome
Timeframe: baseline and week 4Population: The ratio of CD8/CD4 in the periablated zone around the tumor is described as mean of the ratios of CD8/CD4 in each patient collected by ultrasound guided needle biopsy in the peri-ablated tumor area (within 10mm of ablation margin)
How many of the immune cells inside a tumor are a specific type of "killer" T cell
Outcome measures
| Measure |
Arm A: 1st Dose of Pembrolizumab After HIFU
n=6 Participants
Pembrolizumab (200 mg) administered intravenously, days 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Pembrolizumab: Pembrolizumab (200 mg)
High-intensity focused ultrasound (HIFU): Ablation will target 50% of the tumor, up to 3 cubic centimeters
|
Arm B: 1st Dose of Pembrolizumab Before HIFU
n=7 Participants
Pembrolizumab (200 mg) intravenously, days 1, 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Pembrolizumab: Pembrolizumab (200 mg)
High-intensity focused ultrasound (HIFU): Ablation will target 50% of the tumor, up to 3 cubic centimeters
|
|---|---|---|
|
Change in Proportion of CD8+ Tumor Infiltrating Lymphocytes
|
35.98 ratio of CD8 to CD4
Standard Deviation 64.38
|
126.39 ratio of CD8 to CD4
Standard Deviation 216.16
|
Adverse Events
Arm A: 1st Dose of Pembrolizumab After HIFU
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm B: 1st Dose of Pembrolizumab Before HIFU
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: 1st Dose of Pembrolizumab After HIFU
n=6 participants at risk
Pembrolizumab (200 mg) administered intravenously, days 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Pembrolizumab: Pembrolizumab (200 mg)
High-intensity focused ultrasound (HIFU): Ablation will target 50% of the tumor, up to 3 cubic centimeters
|
Arm B: 1st Dose of Pembrolizumab Before HIFU
n=7 participants at risk
Pembrolizumab (200 mg) intravenously, days 1, 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Pembrolizumab: Pembrolizumab (200 mg)
High-intensity focused ultrasound (HIFU): Ablation will target 50% of the tumor, up to 3 cubic centimeters
|
|---|---|---|
|
Investigations
Blood Bilirubin Increased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
General disorders
Fever
|
0.00%
0/6 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Investigations
Alkaline Phosphatase Increased
|
0.00%
0/6 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
28.6%
2/7 • Number of events 2 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
28.6%
2/7 • Number of events 2 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
Other adverse events
| Measure |
Arm A: 1st Dose of Pembrolizumab After HIFU
n=6 participants at risk
Pembrolizumab (200 mg) administered intravenously, days 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Pembrolizumab: Pembrolizumab (200 mg)
High-intensity focused ultrasound (HIFU): Ablation will target 50% of the tumor, up to 3 cubic centimeters
|
Arm B: 1st Dose of Pembrolizumab Before HIFU
n=7 participants at risk
Pembrolizumab (200 mg) intravenously, days 1, 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Pembrolizumab: Pembrolizumab (200 mg)
High-intensity focused ultrasound (HIFU): Ablation will target 50% of the tumor, up to 3 cubic centimeters
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
42.9%
3/7 • Number of events 3 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
42.9%
3/7 • Number of events 3 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
General disorders
Pain
|
33.3%
2/6 • Number of events 2 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
General disorders
Bruising
|
33.3%
2/6 • Number of events 2 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Investigations
Weight Loss
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
28.6%
2/7 • Number of events 2 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
28.6%
2/7 • Number of events 2 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 2 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
28.6%
2/7 • Number of events 2 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
0.00%
0/7 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/6 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
28.6%
2/7 • Number of events 2 • AEs were collected from the time treatment begins until end of treatment (about 1 year).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place