Active Clinical Trials
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.
Stanford is currently accepting patients for this trial.
Intervention(s):
- biological: Placebo
- biological: GLSI-100
Eligibility
Inclusion Criteria:
- HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer
- Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast
cancer therapy
- Stage I, II, or III at presentation with pathologic evidence of residual invasive
carcinoma in the breast or axillary lymph nodes (residual disease) at surgery
following completion of neoadjuvant therapy -OR- Stage III at presentation with
pathologic complete response (pCR) at surgery following completion of neoadjuvant
therapy
- The subject can begin study therapy within one year of completion of adjuvant
trastuzumab-based therapy and any other standard therapies, but, study therapy can be
administered concurrently with endocrine therapy.
- No clinical evidence of residual or persistent breast cancer per treating physician
assessment
- ECOG 0-2
- Adequate organ function
- Negative pregnancy test or evidence of post-menopausal status
- If of childbearing potential, willing to use a form of highly effective contraception
Exclusion Criteria:
- Stage IV cancer or metastatic breast cancer at any time
- Inflammatory breast cancer
- Receiving other investigational agents
- Receiving chemotherapy
- Requiring long-term systemic treatment with corticosteroids or other immunosuppressive
therapy
- History of immunodeficiency or active autoimmune disease
- A history of serious allergic reactions, including anaphylaxis, to human
granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived
products, or any component of the investigational product
- Other malignancies except adequately treated in situ carcinoma of the cervix or basal
cell or squamous cell carcinoma of the skin
- Active infection
- Known HIV infection with a detectable viral load within 6 months of the anticipated
start of treatment. Note: Subjects on effective antiretroviral therapy with an
undetectable viral load within 6 months of the anticipated start of treatment are
eligible for this trial.
Ages Eligible for Study
18 Years - 100 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Le
michmle@stanford.edu
I'm interested