Senior Member
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
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Re: Same vaccine as Lani posted? If not, is anyone getting this?
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)
__________________
Diagnosed 2007
Stage IIb Invasive Ductal Carcinoma, Pagets, 3 of 15 positive nodes
Traditional Treatment: Mastectomy and Axillary Node Dissection followed by Taxotere, 6 treatments and 1 year of Herceptin, no radiation
Former Chemo Ninja "Takizi Zukuchiri"
Additional treatments:
GP2 vaccine, San Antonio Med Ctr
Prescriptive Exercise for Cancer Patients
ENERGY Study, UCSD La Jolla
Reconstruction: TRAM flap, partial loss, Revision
The content of my posts are meant for informational purposes only. The medical information is intended for general information only and should not be used in any way to diagnose, treat, cure, or prevent disease
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