Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00952692|
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : December 20, 2021
Last Update Posted : December 20, 2021
This is a phase I/II study to determine the safety and gain insight into the immune response of the immunologic agent dHER2+AS15 ASCI when administered in combination with lapatinib. This study is for patients with metastatic breast cancer (invasive breast cancer with stage IV disease) that overexpresses HER2 and is resistant to trastuzumab (Herceptin).
The dHER2 + AS15 candidate Antigen-Specific Cancer Immunotherapeutic (ASCI) contains a recombinant protein termed dHER2, which is a truncated version of the HER2 protein. HER2 is a protein that is commonly overexpressed in breast cancer. This protein is combined with the immunological adjuvant AS15 Adjuvant System from GSK (GlaxoSmithKline), which is a liposomal formulation containing three immunostimulatory components.
Lapatinib is FDA approved for use in combination with capecitabine for the treatment of subjects with advanced or metastatic breast cancer whose tumors overexpress HER2.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Biological: dHER2 + AS15 ASCI Drug: Lapatinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Monocentric, Open-label Phase I/II Study to Assess dHER2+AS15 Cancer Immunotherapeutic Given in Combination With Lapatinib to Patients With ErbB2 Overexpressing Metastatic Breast Cancer Refractory to Trastuzumab|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||April 2012|
- Biological: dHER2 + AS15 ASCI
Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine.
For each dose of 500µg of dHER2 + AS15 ASCI, two sterile glass vials will be supplied:
- One vial with the lyophilized preparation containing 500 ug of recombinant dHER2 antigen combined with the immunostimulant.
- One vial with liquid adjuvant diluent. The final dHER2 + AS15 ASCI for administration is obtained by reconstitution of the lyophilized preparation with the adjuvant diluents. A dHER2 + AS15 ASCI dose consists of 0.5 ml.
- dHER2 ASCI
- dHER2 + AS15
- Drug: Lapatinib
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.Other Name: Tykerb
- The Safety of dHER2+AS15 ASCI When Administered in Combination With Lapatinib Measured by Occurrence of Severe Toxicities (According to CTCAE, Version 3.0) [ Time Frame: 26 weeks ]
- Number of Participants With T-cell Response [ Time Frame: 26 weeks ]Positive response is defined as an increase in 40 spots over pre-vaccination frequency
- Occurrence of Objective Clinical Response (CR or PR) as Best Overall Response. [ Time Frame: 26 weeks ]
- Time to Progression [ Time Frame: 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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952692
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Michael Morse, MD||Duke University|