This trial is currently seeking participants
Researchers seek 700 women for a Phase III clinical trial in which they will study the safety and effectiveness of NeuVax, a vaccine designed to prevent or delay breast cancer recurrence in women with tumors that do not overexpress, or have too many, HER2 proteins.
NeuVax may offer benefit as an HER2-targeting treatment for breast cancers that have some HER2 expression, but not enough to be classified as HER2 positive tumors.
At diagnosis, tumors are tested for estrogen receptor (ER), progesterone receptor (PR) and HER2 expression. They are then classified as ER or PR positive or negative, HER2 positive or negative, or triple-negative.
Whether your tumor tests hormone positive or HER2 positive affects what treatments you receive: Women with ER positive tumors receive anti-estrogen therapies, while women with tumors that overexpress HER2 receive trastuzumab (Herceptin). Yet, in some cases a tumor may show signs of being only slightly HER2 positive. These cancers usually do not respond to anti-HER2 therapies because their growth is not driven by overexpression of the HER2 gene.
NeuVax is a small piece of the HER2 protein that works by activating cytotoxic T lymphocytes (white blood cells) to kill HER2-expressing cancer cells. The vaccine is intended to treat cancers that have only low or intermediate levels of HER2 expression. Your pathology report will show your level of HER2 positivity as HER2 1+ (low), HER2 2+ (intermediate) or HER2 3+ (high,or HER2 positive). These results come from the Immunohistochemistry, or IHC, test.
The primary goal of this trial is to assess disease-free survival (DFS), the length of time during which participants show no signs of cancer, when treated with NeuVax.
Secondary goals include assessing DFS at 5 and 10 years, and overall survival at 3, 5 and 10 years. Overall survival is the length of time a person lives after enrolling in the study.
Participants will be randomly assigned to one of two arms, or study groups. Neither the participant nor the researchers will know to which arm each person is assigned.
- In the treatment arm, women will receive NeuVax plus sargramostim (Leukine) by injection in four places on the thigh, once a month for 6 months. Sargramostim is used to boost white blood cell counts in chemotherapy patients and is used with NeuVax to boost the immune response to NeuVax peptide. After 6 months, injections will be given the same way once every 6 months, for five treatment sessions.
- In the control arm, women will receive injections of the immune-system booster, sargramostim (Leukine), alone.
The treatment portion of this study will take 36 months to complete. Women will be followed for between 5 and 10 years.
You may be eligible for this clinical trial if you
- are a woman 18 years of age or older
- were diagnosed with node-positive (1-9 positive nodes), early-stage breast cancer
- are less than 9 weeks out from the date they have completed all standard of care treatment (surgery plus chemotherapy, radiation therapy)
- have HER2 tumors with 1+ or 2+ IHC scores and do not qualify for treatment with trastuzumab
- have no evidence of disease
- were never treated with trastuzumab
- are not taking medicines to suppress your immune system
- receive a result of A2/A3+ on a human leukocyte antigen (HLA) test done as part of the screening process. Women who test for A2/A3+ are most likely to respond to the vaccine.
This study is taking place in 119 locations throughout the United States, Canada, Bulgaria, Czech Republic, Hungary, Israel, Poland, Romania, the Russian Federation, Ukraine, and United Kingdom. For full location details and contact information, see NCT01479244 on ClinicalTrials.gov.