Recruiting
Phase 2

DC1 Vaccine & Paclitaxel, Trastuzumab, Pertuzumab

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT05325632

Conditions

HER2-positive Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HER-2 pulsed DC1

Trastuzumab

Pertuzumab

Paclitaxel

Resection surgery

Study Details

Brief summary:

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.

Conditions

HER2-positive Breast Cancer

Study ID

NCT05325632

Start date

Oct 28, 2021

Status verified date

Feb, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

53 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

HER-2 pulsed DC1

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

Trastuzumab

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

Pertuzumab

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

Paclitaxel

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

Resection surgery

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

Primary outcome measure

  • Lead in Phase: Immunogenicity of each dose level [ Time Frame: at 4 weeks ]
  • Expansion Phase: Pathologic Complete Response Rate [ Time Frame: at 12 months ]

Central Contacts and Locations

Central contacts

Neveen Abdo

813-745-4412Neveen.Abdo@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Hyo Han, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Breast Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-03-02.