Trial Outcomes & Findings for HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer (NCT NCT02063724)
NCT ID: NCT02063724
Last Updated: 2025-11-18
Results Overview
Number of participants willing and able to complete treatment regimen, to address feasibility.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
12 months
Results posted on
2025-11-18
Participant Flow
Participants were enrolled October 2014 through June 2017 at Abramson Cancer Center of the University of Pennsylvania and Moffitt Cancer Center.
Participant milestones
| Measure |
HER-2 Pulsed Dendritic Cell Vaccine
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
HER-2 pulsed Dendritic Cell Vaccine: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
HER-2 Pulsed Dendritic Cell Vaccine
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
HER-2 pulsed Dendritic Cell Vaccine: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
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|---|---|
|
Overall Study
Disease progression
|
1
|
Baseline Characteristics
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer
Baseline characteristics by cohort
| Measure |
HER-2 Pulsed Dendritic Cell Vaccine
n=15 Participants
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
HER-2 pulsed Dendritic Cell Vaccine: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
|
|---|---|
|
Age, Continuous
|
52 years
n=202 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=202 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=202 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=202 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=202 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All participants.
Number of participants willing and able to complete treatment regimen, to address feasibility.
Outcome measures
| Measure |
HER-2 Pulsed Dendritic Cell Vaccine
n=15 Participants
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
HER-2 pulsed Dendritic Cell Vaccine: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
|
|---|---|
|
Rate of Treatment Regimen Completion
|
14 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants.
Number of participants with immune response. Participants will undergo leukapheresis after completion of 6 vaccines and 3 boost vaccines for the purpose of obtaining lymphocytes and monocytes for in vitro immunologic testing.
Outcome measures
| Measure |
HER-2 Pulsed Dendritic Cell Vaccine
n=15 Participants
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
HER-2 pulsed Dendritic Cell Vaccine: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
|
|---|---|
|
Immune Response
|
15 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All participants.
Adverse Events reported as Related to Study Treatment, per adverse event category.
Outcome measures
| Measure |
HER-2 Pulsed Dendritic Cell Vaccine
n=15 Participants
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
HER-2 pulsed Dendritic Cell Vaccine: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
|
|---|---|
|
Occurrence of Treatment Related Adverse Events
Rash
|
1 Participants
|
|
Occurrence of Treatment Related Adverse Events
Citrate toxicity
|
2 Participants
|
|
Occurrence of Treatment Related Adverse Events
Allergic reaction to pheresis
|
1 Participants
|
|
Occurrence of Treatment Related Adverse Events
Tingling with pheresis
|
1 Participants
|
|
Occurrence of Treatment Related Adverse Events
Fatigue
|
1 Participants
|
|
Occurrence of Treatment Related Adverse Events
Chills
|
2 Participants
|
|
Occurrence of Treatment Related Adverse Events
Fever
|
2 Participants
|
|
Occurrence of Treatment Related Adverse Events
Bruising at site of injection
|
1 Participants
|
|
Occurrence of Treatment Related Adverse Events
Lips and finger numbness and tingling
|
1 Participants
|
Adverse Events
HER-2 Pulsed Dendritic Cell Vaccine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HER-2 Pulsed Dendritic Cell Vaccine
n=15 participants at risk
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
HER-2 pulsed Dendritic Cell Vaccine: 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
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|---|---|
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Vascular disorders
Hypertension
|
60.0%
9/15 • Number of events 15 • 2 years
|
|
Infections and infestations
Axillary fullness
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Infections and infestations
Port infection
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Infections and infestations
Cellulitis port site
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Nervous system disorders
Seizures
|
6.7%
1/15 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Citrate toxicity
|
13.3%
2/15 • Number of events 2 • 2 years
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 2 • 2 years
|
|
Immune system disorders
Allergic reaction to pheresis
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Nervous system disorders
Tingling
|
13.3%
2/15 • Number of events 2 • 2 years
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 3 • 2 years
|
|
General disorders
Chills
|
13.3%
2/15 • Number of events 5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
6.7%
1/15 • Number of events 2 • 2 years
|
|
General disorders
Fever
|
13.3%
2/15 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
Bruising at site of injection (LEFT groin)
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Nervous system disorders
Lip paresthesia
|
6.7%
1/15 • Number of events 1 • 2 years
|
Additional Information
Dr. Brian Czerniecki
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-7575
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place