Breast Cancer
Conditions
Keywords
Ductal carcinoma in situ (DCIS)
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.
Interventions
BIOLOGICALHER-2 pulsed DC1
Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.
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.
DRUGpertuzumab
Pertuzumab 420 mg IV will be given at the same time as trastuzumab.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed