WithdrawnNCT02336984Updated Jan 11, 2021

A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS

A Phase 1/2 interventional study of HER-2 pulsed DC1 and trastuzumab in Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Withdrawn at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-11.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn

PI left Abramson Cancer Center and study never opened at Moffitt Cancer Center.

From the registry’s dates

Registered 7 months after the study started (first participant enrolled Jun 2014, registered Jan 2015).

Phase: Phase 1/2
Study type: Interventional
Enrollment: 0
Allocation: Not applicable
Ages: 18 Years and older
Sex: Female

Study summary

The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab.

This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.

Conditions studied

Breast Cancer

Keywords

Ductal carcinoma in situ (DCIS)

In context

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Women >= 18 years.
Ductal carcinoma in situ (DCIS) that express HER-2 3+ on 10% of the DCIS that have not had definitive surgery are diagnosed by core biopsy or NL surgical biopsy with positive margins.
Patients that are ER+ will take anti-estrogen therapy for treatment of their DCIS during vaccinations.
Women of childbearing age with a negative pregnancy test documented prior to enrollment.
Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.

Exclusion criteria

Exclusion Criteria

Pregnant or lactating.
Positive for HIV or hepatitis C at baseline by self-report.
Potential participants with coagulopathies, including thrombocytopenia with platelet count \<75,000, INR> 1.5 and partial thromboplastin time > 50 sec
Major cardiac illness MUGA or ECHO \<50% EF.
Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

Experimental
Combination Therapy
Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.
Biological: HER-2 pulsed DC1 · Drug: trastuzumab · Drug: pertuzumab

Interventions

BiologicalHER-2 pulsed DC1
Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.
Also known as: vaccine
Drugtrastuzumab
The loading dose of Trastuzumab will be 8 mg/kg and the maintenance dose given week 4 will be 6 mg/kg, both standard doses of trastuzumab.
Also known as: Herceptin
Drugpertuzumab
Pertuzumab 420 mg IV will be given at the same time as trastuzumab.
Also known as: Perjeta

What researchers measure

Primary outcomes

Occurrence of Related Adverse Events (AEs)
Occurrence of AEs related to study treatment. Adverse Events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) V 4.02.
Time frame: 5 years

Study locations

2 sites

H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02336984
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Responsible party: Sponsor
First posted: Jan 13, 2015
Start date: Jun 2014
Primary completion: Apr 4, 2016
Completion: Apr 4, 2016
Last update: Jan 11, 2021

Study contacts

Brian Czerniecki, M.D., Ph.D.

principal investigator · H. Lee Moffitt Cancer Center and Research Institute

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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