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

Phase 1

Withdrawn

• Conditions: Breast Cancer
• Interventions: Biological: HER-2 pulsed DC1; Drug: trastuzumab; Drug: pertuzumab

• Registration Number: NCT02336984
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-13
• Primary Completion: 2016-04-04
• Study Completion: 2016-04-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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).

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combination Therapy	pertuzumab	Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.
Combination Therapy	trastuzumab	Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.
Combination Therapy	HER-2 pulsed DC1	Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.

Primary Outcome Measures

Name	Time	Method
Occurrence of Related Adverse Events (AEs)	5 years	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.

Trial Locations

Locations (2)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States