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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Drug: trastuzumab; Biological: HER-2 pulsed DC1; Drug: pertuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02336984

UPCC 03114

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Combination Therapy

Experimental group

Description:

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

Treatment:

Drug: pertuzumab

Biological: HER-2 pulsed DC1

Drug: trastuzumab