A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
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|ClinicalTrials.gov Identifier: NCT02336984|
Recruitment Status : Active, not recruiting
First Posted : January 13, 2015
Last Update Posted : January 3, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: HER-2 pulsed DC1 Drug: trastuzumab Drug: pertuzumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS|
|Actual Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
Experimental: Combination Therapy
Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.
Biological: HER-2 pulsed DC1
Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.
Other Name: vaccine
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.
Other Name: Herceptin
Pertuzumab 420 mg IV will be given at the same time as trastuzumab.
Other Name: Perjeta
- Occurrence of Related Adverse Events (AEs) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336984
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Brian Czerniecki, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|