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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: HER-2 pulsed DC1
* Drug: trastuzumab
* Drug: pertuzumab


Participation Criteria
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Eligibility Criteria
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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 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination Therapy<br>Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab. | Biological: HER-2 pulsed DC1<br>* Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.<br>* Other names: vaccine;Drug: trastuzumab<br>* 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.<br>* Other names: Herceptin;Drug: pertuzumab<br>* Pertuzumab 420 mg IV will be given at the same time as trastuzumab.<br>* Other names: Perjeta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ductal carcinoma in situ (DCIS)