Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-28

Study Completion Date

2026-09-30

Brief Summary

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The purpose of the study is to find out if an investigational drug called Dendritic Cell (DC1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with HER2 (human epidermal growth factor receptor 2) positive breast cancer.

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Detailed Description

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Conditions

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HER2-positive Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lead In - Dose level 1

Six participants will be treated at dose level 1: DC vaccine given at the dose of 50 million once per week for 6 weeks

Group Type EXPERIMENTAL

Resection surgery

Intervention Type PROCEDURE

After week 18, participants will undergo standard of care resection surgery.

HER-2 pulsed DC1

Intervention Type BIOLOGICAL

Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.

Trastuzumab

Intervention Type DRUG

8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks

Pertuzumab

Intervention Type DRUG

840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.

Paclitaxel

Intervention Type DRUG

80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18

Lead In: Dose Level 2

Six participants will be treated at dose level 2: DC vaccine given at the dose of 100 million once per week for 6 weeks

Group Type EXPERIMENTAL

Resection surgery

Intervention Type PROCEDURE

After week 18, participants will undergo standard of care resection surgery.

HER-2 pulsed DC1

Intervention Type BIOLOGICAL

Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.

Trastuzumab

Intervention Type DRUG

8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks

Pertuzumab

Intervention Type DRUG

840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.

Paclitaxel

Intervention Type DRUG

80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18

Expansion -Estrogen Receptor (ER) positive

An additional 24 participants will be enrolled at dose level 2 if determined to be safe in lead in phase to have a total of 28 evaluable participants for pathologic response assessment (including 6 pts from the lead in phase).

Group Type EXPERIMENTAL

Resection surgery

Intervention Type PROCEDURE

After week 18, participants will undergo standard of care resection surgery.

HER-2 pulsed DC1

Intervention Type BIOLOGICAL

Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.

Trastuzumab

Intervention Type DRUG

8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks

Pertuzumab

Intervention Type DRUG

840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.

Paclitaxel

Intervention Type DRUG

80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18

Expansion -Estrogen Receptor (ER) negative

An additional 23 participants will be enrolled at dose level 2 if determined to be safe in lead in phase to have a total of 28 evaluable participants for pathologic response assessment (including 6 pts from the lead in phase).

Group Type EXPERIMENTAL

Resection surgery

Intervention Type PROCEDURE

After week 18, participants will undergo standard of care resection surgery.

HER-2 pulsed DC1

Intervention Type BIOLOGICAL

Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.

Trastuzumab

Intervention Type DRUG

8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks

Pertuzumab

Intervention Type DRUG

840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.

Paclitaxel

Intervention Type DRUG

80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18

Interventions

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Resection surgery

After week 18, participants will undergo standard of care resection surgery.

Intervention Type PROCEDURE

HER-2 pulsed DC1

Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.

Intervention Type BIOLOGICAL

Trastuzumab

8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks

Intervention Type DRUG

Pertuzumab

840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.

Intervention Type DRUG

Paclitaxel

80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18

Intervention Type DRUG

Other Intervention Names

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Herceptin Perjeta Abraxane

Eligibility Criteria

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Inclusion Criteria

* Participants must have histologically confirmed clinical stage I- III, HER2+ (per ASCO/CAP criteria) invasive carcinoma of the breast. Primary tumor should measure at least 1 cm by clinical exam or radiologic tests
* Candidate for neoadjuvant chemotherapy with Paclitaxel, Trastuzumab, Pertuzumab regimen followed by standard of care local therapy as determined by the treating physician
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Participants must have normal organ and marrow function as defined per protocol.
* Cardiac ejection fraction within institutional normal limits by either Multigated Acquisition Scan (MUGA) or Echocardiogram 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

* Participants with inflammatory breast cancer, widespread locally advanced unresectable disease involving the chest wall/nodal basins in which a curative surgical resection cannot be performed, or those in whom de novo metastatic disease is suspected or confirmed.
* Patients 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 (paclitaxel, trastuzumab, pertuzumab).
* Participants who are 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.
* Pregnant women and women who are breastfeeding.
* Participants with known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No