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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Enrolling; Phase 2

Conditions: HER2-positive Breast Cancer

Treatments: Drug: Pertuzumab; Procedure: Resection surgery; Drug: Paclitaxel; Biological: HER-2 pulsed DC1; Drug: Trastuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05325632

MCC-20915

Details and patient eligibility

About

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.

Enrollment: 53 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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53 participants in 4 patient groups

Lead In - Dose level 1

Experimental group

Description:

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

Treatment:

Drug: Trastuzumab

Biological: HER-2 pulsed DC1

Drug: Paclitaxel

Procedure: Resection surgery

Drug: Pertuzumab

Lead In: Dose Level 2

Experimental group

Description:

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

Treatment:

Drug: Trastuzumab

Biological: HER-2 pulsed DC1

Drug: Paclitaxel

Procedure: Resection surgery

Drug: Pertuzumab

Expansion -Estrogen Receptor (ER) positive

Experimental group

Description:

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).

Treatment:

Drug: Trastuzumab

Biological: HER-2 pulsed DC1

Drug: Paclitaxel

Procedure: Resection surgery

Drug: Pertuzumab

Expansion -Estrogen Receptor (ER) negative

Experimental group

Description:

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).

Treatment:

Drug: Trastuzumab

Biological: HER-2 pulsed DC1

Drug: Paclitaxel

Procedure: Resection surgery

Drug: Pertuzumab