Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments her-2 pulsed dc1, trastuzumab, pertuzumab
Phase phase 1/phase 2
Target HER2
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Start date June 2014
End date June 2019
Trial size 5 participants
Trial identifier NCT02336984, UPCC 03114

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.
her-2 pulsed dc1 vaccine
Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.
trastuzumab Herceptin
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.
pertuzumab Perjeta
Pertuzumab 420 mg IV will be given at the same time as trastuzumab.

Primary Outcomes

Measure
Occurrence of Related Adverse Events (AEs)
time frame: 5 years

Eligibility Criteria

Female participants at least 18 years old.

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).

Additional Information

Official title A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
Principal investigator Brian Czerniecki, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.