The purpose of this study is to learn more about how to treat patients with a diagnosis of
diagnosis of Human Epidermal Growth Factor Receptor 2/neu (HER-2/neu) positive breast cancer
in the past, who were previously treated with HER-2/neu-directed dendritic cells (DC)
There is evidence that the use of anti-HER2 dendritic cell (DC) study vaccines could improve
response to breast cancer therapy and be an important step in the prevention of recurrence.
This study will use a Dendritic Cell Type 1 (DC1) vaccine which is a HER2-sensitized
dendritic cell (DC) study vaccine. Dendritic cells are immune cells that can tell the
participant's immune system to fight infection. This study vaccine will be made from the
participant's blood cells collected from a procedure called leukapheresis.
- Patients with a diagnosis of nonmetastatic classic HER2pos (ie, IHC 3+ or FISHpos)
breast cancer (BC) who have previously been vaccinated with DC1 HER2-pulsed vaccines
on any of several prior clinical trials for ductal carcinoma in situ (DCIS) or
inflammatory breast cancer (IBC) are eligible; however, we also allowed HER2 2+
patients in many of these prior trials and they will also be allowed to participate in
this trial. Note: HER2pos BC is defined by tumor tissue HER2 overexpression and or
tumor HER2 amplification. The lack of HER2 overexpression by IHC is defined as 0 or 1+
whereas overexpression is defined as 3+. In the event of equivocal IHC, 2+, the tumor
must be gene-amplified by fluorescent in situ hybridization (FISH) performed upon the
primary tumor or metastatic lesion (ratio > 2 and HER2 copy number > 4 define
- Participants must have completed all standard-of-care treatment for nonmetastatic BC
(e.g., surgery, chemotherapy, radiation therapy, and HER2-targeted therapy). Note:
antiestrogen therapy is permitted while on trial.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Participants must have normal organ and marrow function within 2 weeks of
- Left ventricular ejection fraction above institutional lower limit of normal (by
echocardiogram or multigated acquisition (MUGA) scan within 6 months of registration).
- For both male and female patients, effective methods of contraception must be used
throughout the study and for 3 months following the last dose.
- Must have the ability to understand and the willingness to sign a written informed
consent prior to registration on study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, congenital prolonged QT syndrome, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
that would limit compliance with study requirements.
- Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular,
intra-articular, intranasal, inhalational corticosteroids (with minimal systemic
absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30 days
prior to starting study drug will be excluded.
- No other prior malignancy is allowed except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Any other cancer from which the patient has been disease free for at least 3
- Pregnant or breast feeding.
- Known to be HIV positive.
- Known current or a history of hepatitis B or C virus, including chronic and dormant
states, unless disease has been treated and confirmed cleared.
- Major surgery within 4 weeks of initiation of study drug.
- Have not recovered to ≤ Grade 1 or tolerable Grade 2 adverse events (AEs) due to
agents administered ≥ 28 days earlier, as documented by the treating investigator.
- Currently enrolled in any other clinical protocol or investigational trial that
involves administration of experimental therapy and/or therapeutic devices, or
- Not able to comply with the treatment schedule and study procedures for any reason.
- Have stage IV BC.