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HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer (Adjuvant)

Primary Purpose

Breast Cancer

Status

Completed

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

Eligibility Criteria

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

Inclusion Criteria:

Women over Age 18 years.
Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than or equal to N2 (>4 positive nodes) or have recurrent metastatic breast cancer rendered NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+ FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1 year from their last treatment and have no evidence of disease.
Deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations.
Women of childbearing age with a negative pregnancy test documented prior to enrollment.
Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
Willing to use birth control if necessary.
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 positive HIV or hepatitis C at baseline.
Patients with coagulopathies, including thrombocytopenia with platelet count less than 75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.
Major cardiac illness MUGA less than 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. 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.

Outcomes

Primary Outcome Measures

Rate of Treatment Regimen Completion

Number of participants willing and able to complete treatment regimen, to address feasibility.

Secondary Outcome Measures

Immune Response

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.

Occurrence of Treatment Related Adverse Events

Adverse Events reported as Related to Study Treatment, per adverse event category.

Full Information

NCT ID

NCT02063724

First Posted

February 6, 2014

Last Updated

October 17, 2023

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02063724

Brief Title

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

Acronym

Adjuvant

Official Title

Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2014 (Actual)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

September 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Abramson Cancer Center at Penn Medicine

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 purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram, laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine administration.

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. Participants with HER-2 driven IBC at least Stage IIIA with N2 (4 positive nodes) following chemotherapy with or without trastuzumab or those with recurrence exclusive of new primary tumor but rendered NED will be undergo mammograms, laboratory studies, and leukapheresis. Vaccines will be manufactured using participants' leukapheresis product, which will be administered in the Clinical Research Center 1 Dulles Building weekly for 6 weeks. Three booster vaccines will be administered at 3 month intervals following the initial induction vaccines. Immune analysis will be done after participant receives all induction vaccines and again after they receive all booster vaccines. 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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HER-2 Pulsed Dendritic Cell Vaccine

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

HER-2 pulsed Dendritic Cell Vaccine

Intervention Description

Primary Outcome Measure Information:

Title

Rate of Treatment Regimen Completion

Description

Number of participants willing and able to complete treatment regimen, to address feasibility.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Immune Response

Description

Time Frame

12 months

Title

Occurrence of Treatment Related Adverse Events

Description

Adverse Events reported as Related to Study Treatment, per adverse event category.

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women over Age 18 years. Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than or equal to N2 (>4 positive nodes) or have recurrent metastatic breast cancer rendered NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+ FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1 year from their last treatment and have no evidence of disease. Deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations. Women of childbearing age with a negative pregnancy test documented prior to enrollment. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1. Willing to use birth control if necessary. 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 positive HIV or hepatitis C at baseline. Patients with coagulopathies, including thrombocytopenia with platelet count less than 75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec. Major cardiac illness MUGA less than 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

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