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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05325632
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HER-2 pulsed DC1 — BIOLOGICAL
    Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.
  • Trastuzumab — DRUG
    8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks
  • Pertuzumab — DRUG
    840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.
  • Paclitaxel — DRUG
    80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18
  • Resection surgery — PROCEDURE
    After week 18, participants will undergo standard of care resection surgery.

Study Details

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.

Key Dates

Start date
Oct 28, 2021
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
53 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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
  • Experimental: 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).
  • Experimental: 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).

Primary Outcome Measure

Lead in Phase: Immunogenicity of each dose level [ Time Frame: at 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Hyo Han, MD (PRINCIPAL_INVESTIGATOR)
Avan Armaghani, MD (SUB_INVESTIGATOR)
Ricardo Costa, MD, MSc (SUB_INVESTIGATOR)
Brian Czerniecki, MD, PhD (SUB_INVESTIGATOR)
Martine Extermann, MD, PhD (SUB_INVESTIGATOR)
Hung Khong, MD (SUB_INVESTIGATOR)
Kimberley Lee, MD, MHS (SUB_INVESTIGATOR)
Loretta Loftus, MD, MBA (SUB_INVESTIGATOR)
Christine Sam, MD (SUB_INVESTIGATOR)
Hatem Soliman, MD (SUB_INVESTIGATOR)
Aixa Soyano Muller, MD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Moffitt Cancer Center· Tampa, FL

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