HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy (Neoadjuvant)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02061423 |
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Recruitment Status :
Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : January 26, 2023
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Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
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Brief Summary:
The primary goals of this trial will be to determine the safety and immune activity of HER-2 pulsed DC1 vaccine in patients with high risk HER-2pos breast cancer with residual disease post neoadjuvant therapy. Investigators will also explore the possibility of determining whether circulating tumor cells can be used as surrogate to assess response to vaccination.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Biological: HER-2 pulsed Dendritic Cell Vaccine | Phase 1 |
Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prevention of breast cancer in high risk settings. There is a need to determine whether this ICAIT DC1 can activate CD4 and CD8 T cells prior to or in combination with chemotherapy with or without added trastuzumab.
This study began at the Abramson Cancer Center of the University of Pennsylvania and will be continued at H. Lee Moffitt Cancer Center and Research Institute.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 7 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer Post Neoadjuvant Chemotherapy |
| Actual Study Start Date : | April 8, 2014 |
| Actual Primary Completion Date : | February 2019 |
| Estimated Study Completion Date : | December 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: HER-2 Pulsed Dendritic Cell Vaccine
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months.
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Biological: HER-2 pulsed Dendritic Cell Vaccine
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. |
Primary Outcome Measures :
- Participation Compliance [ Time Frame: Up to 18 months ]Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (6 weekly vaccinations). Data collection will include rate of successful completion and occurrence rate for each reason stated for non-completion.
- Occurrence of Treatment Related Adverse Events [ Time Frame: Up to 18 months ]Number of participants with treatment related adverse events, per event category.
Secondary Outcome Measures :
- Immunogenicity [ Time Frame: Up to 5 years follow-up ]Immunogenicity will be evaluated by descriptive statistics, plots of pre- and post-treatment values and fold changes. Immune response rate and 95% exact confidence interval will be calculated.
- Anti-HER2 Immunity [ Time Frame: Up to 5 years follow-up ]Anti-HER2 response will be quantitated as EOS/baseline fold change in dilution studies.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women ≥ 18 years.
- HER-2 expressing stage I - III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy.
- Women of childbearing age with a negative pregnancy serum test documented prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
- Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
- Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
Exclusion Criteria:
- Pregnant or lactating.
- Positive for HIV or hepatitis C at baseline by self report.
- Potential participants with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec.
- Potential participants with MUGA < 50% EF.
- Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
Information from the National Library of Medicine
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): NCT02061423
Locations
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
| Principal Investigator: | Brian Czerniecki, M.D., Ph.D. | H. Lee Moffitt Cancer Center and Research Institute |
Additional Information:
Publications:
Publications:
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT02061423 |
| Obsolete Identifiers: | NCT02110199 |
| Other Study ID Numbers: |
MCC-18776 UPCC26113 ( Other Identifier: CTSRMC, Abramson Cancer Center, University of Pennsylvania ) |
| First Posted: | February 12, 2014 Key Record Dates |
| Last Update Posted: | January 26, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
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Invasive Breast Cancer Breast Cancer Immunotherapy |
Vaccine Dendritic Cell Neoadjuvant |
Additional relevant MeSH terms:
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Breast Neoplasms Recurrence Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Disease Attributes Pathologic Processes |