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HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy (Neoadjuvant)

Primary Purpose

Breast Cancer

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

HER-2 pulsed Dendritic Cell Vaccine

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Invasive Breast Cancer, Breast Cancer, Immunotherapy, Vaccine, Dendritic Cell, Neoadjuvant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

H. Lee Moffitt Cancer Center and Research Institute
Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HER-2 Pulsed Dendritic Cell Vaccine

Arm Description

6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months.

Outcomes

Primary Outcome Measures

Participation Compliance

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

Number of participants with treatment related adverse events, per event category.

Secondary Outcome Measures

Immunogenicity

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

Anti-HER2 response will be quantitated as EOS/baseline fold change in dilution studies.

Full Information

NCT ID

NCT02061423

First Posted

February 10, 2014

Last Updated

June 30, 2023

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02061423

Brief Title

HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy

Acronym

Neoadjuvant

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 8, 2014 (Actual)

Primary Completion Date

February 2019 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Invasive Breast Cancer, Breast Cancer, Immunotherapy, Vaccine, Dendritic Cell, Neoadjuvant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HER-2 Pulsed Dendritic Cell Vaccine

Arm Type

Experimental

Arm Description

6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months.

Intervention Type

Biological

Intervention Name(s)

HER-2 pulsed Dendritic Cell Vaccine

Intervention Description

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 Measure Information:

Title

Participation Compliance

Description

Time Frame

Up to 18 months

Title

Occurrence of Treatment Related Adverse Events

Description

Number of participants with treatment related adverse events, per event category.

Time Frame

Up to 18 months

Secondary Outcome Measure Information:

Title

Immunogenicity

Description

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.

Time Frame

Up to 5 years follow-up

Title

Anti-HER2 Immunity

Description

Anti-HER2 response will be quantitated as EOS/baseline fold change in dilution studies.

Time Frame

Up to 5 years follow-up

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Czerniecki, M.D., Ph.D.

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

H. Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Hospital of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17638860

Citation

Czerniecki BJ, Roses RE, Koski GK. Development of vaccines for high-risk ductal carcinoma in situ of the breast. Cancer Res. 2007 Jul 15;67(14):6531-4. doi: 10.1158/0008-5472.CAN-07-0878.

Results Reference

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PubMed Identifier

17293384

Citation

Czerniecki BJ, Koski GK, Koldovsky U, Xu S, Cohen PA, Mick R, Nisenbaum H, Pasha T, Xu M, Fox KR, Weinstein S, Orel SG, Vonderheide R, Coukos G, DeMichele A, Araujo L, Spitz FR, Rosen M, Levine BL, June C, Zhang PJ. Targeting HER-2/neu in early breast cancer development using dendritic cells with staged interleukin-12 burst secretion. Cancer Res. 2007 Feb 15;67(4):1842-52. doi: 10.1158/0008-5472.CAN-06-4038. Epub 2007 Feb 9.

Results Reference

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PubMed Identifier

22130160

Citation

Koski GK, Koldovsky U, Xu S, Mick R, Sharma A, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Czerniecki BJ. A novel dendritic cell-based immunization approach for the induction of durable Th1-polarized anti-HER-2/neu responses in women with early breast cancer. J Immunother. 2012 Jan;35(1):54-65. doi: 10.1097/CJI.0b013e318235f512.

Results Reference

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PubMed Identifier

22252842

Citation

Sharma A, Koldovsky U, Xu S, Mick R, Roses R, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Koski G, Czerniecki BJ. HER-2 pulsed dendritic cell vaccine can eliminate HER-2 expression and impact ductal carcinoma in situ. Cancer. 2012 Sep 1;118(17):4354-62. doi: 10.1002/cncr.26734. Epub 2012 Jan 17.

Results Reference

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Links:

URL

https://moffitt.org/clinical-trials-research/

Description

Moffitt Cancer Center Clinical Trials website

Learn more about this trial

HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy

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