Trial Outcomes & Findings for Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer (NCT NCT00952692)

NCT ID: NCT00952692

Last Updated: 2021-12-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 26 weeks
• Results posted on: 2021-12-20

Participant Flow

Participant milestones

Measure	dHER2 + AS15 ASCI + Lapatinib Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	dHER2 + AS15 ASCI + Lapatinib n=12 Participants Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 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	0 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	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks

Outcome measures

Measure	dHER2 + AS15 ASCI + Lapatinib n=12 Participants Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
The Safety of dHER2+AS15 ASCI When Administered in Combination With Lapatinib Measured by Occurrence of Severe Toxicities (According to CTCAE, Version 3.0)	0 Participants

PRIMARY outcome

Timeframe: 26 weeks

Positive response is defined as an increase in 40 spots over pre-vaccination frequency

Outcome measures

Measure	dHER2 + AS15 ASCI + Lapatinib n=12 Participants Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
Number of Participants With T-cell Response ECD-specific T cell response	1 Participants
Number of Participants With T-cell Response ICD-specific T cell response	0 Participants

SECONDARY outcome

Timeframe: 26 weeks

Outcome measures

Measure	dHER2 + AS15 ASCI + Lapatinib n=12 Participants Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
Occurrence of Objective Clinical Response (CR or PR) as Best Overall Response.	0 Participants

SECONDARY outcome

Timeframe: 26 weeks

Defined as the time from first study treatments administration to documented disease progression or death, and censored at the last date of contact for patients whose disease does not progress. Note: In this definition any progression of lesions will count as "progression".

Outcome measures

Measure	dHER2 + AS15 ASCI + Lapatinib n=12 Participants Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
Time to Progression	55 days Interval 41.0 to 188.0

Adverse Events

dHER2 + AS15 ASCI + Lapatinib

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	dHER2 + AS15 ASCI + Lapatinib n=12 participants at risk Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
Cardiac disorders chest pain	8.3% 1/12
Blood and lymphatic system disorders pulmonary embolism	8.3% 1/12

Other adverse events

Measure	dHER2 + AS15 ASCI + Lapatinib n=12 participants at risk Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.
Musculoskeletal and connective tissue disorders musculoskeletal pain	33.3% 4/12
Skin and subcutaneous tissue disorders injection site reactions	50.0% 6/12
Musculoskeletal and connective tissue disorders myalgia	41.7% 5/12
General disorders fatigue	25.0% 3/12
Gastrointestinal disorders diarrhea	33.3% 4/12
Metabolism and nutrition disorders anorexia	8.3% 1/12
Skin and subcutaneous tissue disorders Hand foot syndrome	8.3% 1/12
Eye disorders Vision change	8.3% 1/12
Infections and infestations infection (thumb)	8.3% 1/12
Metabolism and nutrition disorders hypokalemia	8.3% 1/12
Respiratory, thoracic and mediastinal disorders dyspnea	8.3% 1/12
General disorders fever/chills	25.0% 3/12
Respiratory, thoracic and mediastinal disorders change in voice	8.3% 1/12
Gastrointestinal disorders mucositis	8.3% 1/12
General disorders flu like symptoms	8.3% 1/12
Gastrointestinal disorders dyspepsia	8.3% 1/12
Nervous system disorders neurosensory	16.7% 2/12
Nervous system disorders neuropathy	8.3% 1/12
Skin and subcutaneous tissue disorders dermatology/rash	16.7% 2/12
Nervous system disorders balance/diziness	16.7% 2/12
Nervous system disorders Neuro-motor	8.3% 1/12
Respiratory, thoracic and mediastinal disorders congestion	8.3% 1/12
Respiratory, thoracic and mediastinal disorders cough	8.3% 1/12
Skin and subcutaneous tissue disorders xerosis	8.3% 1/12

Additional Information

Dr. Michael Morse

Duke University

Phone: 919-681-3480

Email: morse004@mc.duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place