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OncoMatch/Clinical Trials/NCT05325632

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

Is NCT05325632 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including HER-2 pulsed DC1 and Trastuzumab for her2-positive breast cancer.

Phase 2RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT05325632Data as of Jun 2026

Treatment: HER-2 pulsed DC1 · Trastuzumab · Pertuzumab · PaclitaxelThe 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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Extracted eligibility criteria

Treatments studied

Targeted therapy

TrastuzumabPertuzumab

Chemotherapy

Paclitaxel

Other

HER-2 pulsed DC1

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression (HER2+ (per ASCO/CAP criteria))

HER2+ (per ASCO/CAP criteria) invasive carcinoma of the breast

Disease stage

Required: Stage I, II, III

clinical stage I- III

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: investigational agent

Patients may not be receiving any other investigational agents for the treatment of their breast cancer.

Lab requirements

Blood counts

normal organ and marrow function as defined per protocol

Kidney function

normal organ and marrow function as defined per protocol

Liver function

normal organ and marrow function as defined per protocol

Cardiac function

Cardiac ejection fraction within institutional normal limits by either Multigated Acquisition Scan (MUGA) or Echocardiogram at baseline.

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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Moffitt Cancer Center · Tampa, Florida

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05325632 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior investigational agent disqualifies patients from enrollment.

Does this trial require ERBB2?

Yes, ERBB2 overexpression is a required biomarker for enrollment.

What disease stage is eligible?

Stage I or II or III is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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