HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer
NCT ID: NCT03387553
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
31 participants
INTERVENTIONAL
2018-06-06
2026-08-29
Brief Summary
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The study drug for this trial is DC1 study vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. This study vaccine is made from the participant's blood cells collected from a procedure called leukapheresis. Dendritic cells are immune cells that can tell the immune system to fight infection. In laboratory testing and from previous studies in participants, these cells may also help the immune system attack tumors such as breast cancer.
Detailed Description
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Arm A: One DC1 study vaccination per week x 3 weeks. Arm B: Two DC1 study vaccinations per week (given 3 days apart for example Mon and Thurs or Tues and Friday) x 3 weeks.
Following accrual of this initial group of 12 participants, HER2 ELISPOT post study vaccination responses will be assessed to determine which of the two sequences provides the greater increase in anti HER2 response at week 4 over baseline. This will determine which sequence will be used in the second expansion phase of accrual. If both arms are determined equal then Arm A will be selected as the default sequence.
Second phase of accrual will consist of 14 additional participants to undergo study vaccination using the optimal schedule declared in the first phase of the trial. The trial will consist of two phases. The first lead in phase will enroll 12 participants evenly divided into two arms (alternating enrollment) with different initial priming study vaccination schedules.
Arm A: One DC1 study vaccination per week x 3 weeks Arm B: Two DC1 study vaccinations per week (given 3 days apart for example Mon and Thurs or Tues and Friday) x 3 weeks.
Following accrual of this initial group of 12 participants, HER2 ELISPOT post study vaccination responses will be assessed to determine which of the two sequences provides the greater increase in anti HER2 response at week 4 over baseline. This will determine which sequence will be used in the second expansion phase of accrual. If both arms are determined equal then Arm A will be selected as the default sequence.
Second phase of accrual will consist of 14 additional participants to undergo study vaccination using the optimal schedule declared in the first phase of the trial.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
Following accrual of this initial group of 12 patients, HER2 ELISPOT post vaccination responses will be assessed to determine which of the two sequences provides the greater increase in anti HER2 response at week 4 over baseline. This will determine which sequence will be used in the second expansion phase of accrual. If both arms are determined equal then Arm A will be selected as the default sequence.
TREATMENT
NONE
Study Groups
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Lead In Phase - Arm A
Arm A: One Dendritic Cell Vaccine (DC1) per week x 3 weeks.
Neoadjuvant Chemotherapy
Upon completion of the 3 week series of vaccinations participants will then undergo neoadjuvant chemotherapy treatment with the TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) standard of care neoadjuvant chemotherapy regimen given intravenously once every 3 weeks for up to 6 cycles. The treating physician will have the discretion to delay, modify, or shorten the neoadjuvant chemotherapy as per routine practice guidelines and physician discretion.
Curative Surgery
Planned definitive curative surgery at 26 to 28 weeks.
Dendritic Cell Vaccine (DC1)
Study Vaccine:
Lead In Phase - Weekly as outlined in each treatment Arm.
Expansion Phase - At the optimal schedule determined at the end of the Lead In Phase.
Pre-surgery - Booster Vaccine at week 25 prior to receiving surgery.
Post-surgery - Participants will receive a series of 3 booster intranodal study vaccines given once every 6 months.
Lead In Phase - Arm B
Arm B: Two DC1 vaccinations per week (given 3 days apart i.e., Mon and Thurs or Tues and Friday) x 3 weeks.
Neoadjuvant Chemotherapy
Upon completion of the 3 week series of vaccinations participants will then undergo neoadjuvant chemotherapy treatment with the TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) standard of care neoadjuvant chemotherapy regimen given intravenously once every 3 weeks for up to 6 cycles. The treating physician will have the discretion to delay, modify, or shorten the neoadjuvant chemotherapy as per routine practice guidelines and physician discretion.
Curative Surgery
Planned definitive curative surgery at 26 to 28 weeks.
Dendritic Cell Vaccine (DC1)
Study Vaccine:
Lead In Phase - Weekly as outlined in each treatment Arm.
Expansion Phase - At the optimal schedule determined at the end of the Lead In Phase.
Pre-surgery - Booster Vaccine at week 25 prior to receiving surgery.
Post-surgery - Participants will receive a series of 3 booster intranodal study vaccines given once every 6 months.
Expansion Phase
DC1 vaccinations according to optimal vaccination schedule. Participants will receive a booster intranodal study vaccine at week 25 prior to receiving surgery. Participants will then undergo definitive curative surgery following completion of the neoadjuvant therapy, additional adjuvant locoregional/systemic therapy (as deemed appropriate by their treating physicians).
Neoadjuvant Chemotherapy
Upon completion of the 3 week series of vaccinations participants will then undergo neoadjuvant chemotherapy treatment with the TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) standard of care neoadjuvant chemotherapy regimen given intravenously once every 3 weeks for up to 6 cycles. The treating physician will have the discretion to delay, modify, or shorten the neoadjuvant chemotherapy as per routine practice guidelines and physician discretion.
Curative Surgery
Planned definitive curative surgery at 26 to 28 weeks.
Dendritic Cell Vaccine (DC1)
Study Vaccine:
Lead In Phase - Weekly as outlined in each treatment Arm.
Expansion Phase - At the optimal schedule determined at the end of the Lead In Phase.
Pre-surgery - Booster Vaccine at week 25 prior to receiving surgery.
Post-surgery - Participants will receive a series of 3 booster intranodal study vaccines given once every 6 months.
Interventions
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Neoadjuvant Chemotherapy
Upon completion of the 3 week series of vaccinations participants will then undergo neoadjuvant chemotherapy treatment with the TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) standard of care neoadjuvant chemotherapy regimen given intravenously once every 3 weeks for up to 6 cycles. The treating physician will have the discretion to delay, modify, or shorten the neoadjuvant chemotherapy as per routine practice guidelines and physician discretion.
Curative Surgery
Planned definitive curative surgery at 26 to 28 weeks.
Dendritic Cell Vaccine (DC1)
Study Vaccine:
Lead In Phase - Weekly as outlined in each treatment Arm.
Expansion Phase - At the optimal schedule determined at the end of the Lead In Phase.
Pre-surgery - Booster Vaccine at week 25 prior to receiving surgery.
Post-surgery - Participants will receive a series of 3 booster intranodal study vaccines given once every 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Medically and surgically appropriate to undergo neoadjuvant chemotherapy with TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) regimen followed by standard of care local therapy as determined by their treating physician
* Age ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status less than 2
* Patients must have normal organ and marrow function as defined below:
* leukocytes ≥3,000/μL
* absolute neutrophil count ≥1,500/μL
* platelets ≥100,000/μL
* total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
* creatinine within normal institutional limits - OR -
* creatinine clearance ≥60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Cardiac ejection fraction within institutional normal limits by either MUGA or ECHO at baseline.
* Women of child-bearing potential and their male partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Sexually active male participants should use a barrier method or exercise abstinence during chemotherapy administration until surgery.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* May not be receiving any other investigational agents for the treatment of their breast cancer.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study vaccine components and any of the chemotherapy drugs (docetaxel, carboplatin, trastuzumab, pertuzumab)
* Unwilling or unable to undergo an apheresis for production of their vaccine
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Women who are pregnant or breastfeeding
* Known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant).
* Pre-existing peripheral neuropathy that would limit treatment with taxanes and platinum agents
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Haten Soliman, M.D.
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Countries
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References
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Soliman H, Aldrich A, Abdo N, Han H, Soyano A, Costa R, Armaghani A, Kiluk J, Khakpour N, Lee MC, Hoover S, Laronga C, Niell B, Mooney B, Weinfurtner RJ, Rosa M, Czerniecki B. A pilot study incorporating HER2-directed dendritic cells into neoadjuvant therapy of early stage HER2+ER- breast cancer. NPJ Breast Cancer. 2025 Mar 17;11(1):29. doi: 10.1038/s41523-025-00742-x.
Related Links
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Moffitt Cancer Center Clinical Trials website
Other Identifiers
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MCC-19337
Identifier Type: -
Identifier Source: org_study_id