['lizbeth]

Hutchibk,

Here is one that starts "July 2012" for low expressors. These vaccine trials have focused more on primary and early breast cancer. This treatment uses E75 and Herceptin.

http://clinicaltrials.gov/ct2/show/N...rceptin&rank=1

Criteria
Inclusion Criteria:

• Patients will be included in the study based on the following criteria:
  
  • Women 18 years or older
  • Node-positive breast cancer (AJCC N1, N2, or N3)
  • Node-negative breast cancer if negative for both estrogen (ER) and progesterone (PR) receptors and has received chemotherapy as standard of care
  • Clinically cancer-free (no evidence of disease) after standard of care therapy (surgery, chemotherapy, radiation therapy as directed by NCCN guidelines). Hormonal therapy will continue per standard of care. Neoadjuvant chemotherapy is allowed.
  • HER2 expression of 1+ or 2+ by IHC. FISH testing must be performed on IHC 2+ tumors and shown to be non-amplified (≤2.0).
  • HLA-A2 and/or HLA-A3 positive
  • LVEF >50%
  • ECOG 0,1
  • Signed informed consent
  • Adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)

Exclusion Criteria:

• Patients will be excluded from the study based on the following criteria
  
  • Node-negative breast cancer (AJCC N0 or N0(i+)) unless negative for both estrogen (ER) and progesterone (PR) receptors and has received chemotherapy as standard of care
  • Clinical or radiographic evidence of distant or residual breast cancer
  • HER2 negative (IHC 0) or HER2 3+ or FISH amplified (FISH >2.0)
  • Non-HLA-A2/3 positivity
  • History of prior Herceptin therapy
  • NYHA stage 3 or 4 cardiac disease
  • LVEF <50%
  • Immune deficiency disease or HIV, HBV, HCV
  • Receiving immunosuppressive therapy including chemotherapy, chronic steroids, methotrexate, or other known immunosuppressive agents
  • ECOG ≥2
  • Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000
  • Pregnancy (assessed by urine HCG)
  • Breast feeding
  • History of autoimmune disease
  • Active pulmonary disease requiring medication to include multiple inhalers
  • Involved in other experimental protocols (except with permission of the other study PI)