NCT02336984

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2016

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

January 9, 2015

Last Update Submit

January 7, 2021

Conditions

Breast Cancer

Keywords

Ductal carcinoma in situ (DCIS)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Combination Therapy

EXPERIMENTAL

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

Biological: HER-2 pulsed DC1Drug: trastuzumabDrug: pertuzumab

Interventions

HER-2 pulsed DC1BIOLOGICAL

Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.

Also known as: vaccine
Combination Therapy
trastuzumabDRUG

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.

Also known as: Herceptin
Combination Therapy
pertuzumabDRUG

Pertuzumab 420 mg IV will be given at the same time as trastuzumab.

Also known as: Perjeta
Combination Therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

VaccinesTrastuzumabpertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Biological ProductsComplex MixturesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Brian Czerniecki, M.D., Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 13, 2015

Study Start

June 1, 2014

Primary Completion

April 4, 2016

Study Completion

April 4, 2016

Last Updated

January 11, 2021

Record last verified: 2021-01

Locations

US(2)