Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax

ID#: NCT01570036

Age: 18 years - 66+

Gender: Female

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: January 01, 2013

End Date: June 01, 2020

Contact Information:
Karen Arrington, RN, BSN, CCRP
210-243-5711
Summary: The study will be a multi-center, prospective, randomized, single-blinded, placebo-controlled Phase II trial of Herceptin + NeuVax(TM) vaccine (E75 peptide/granulocyte macrophage-colony stimulating factor) (GM-CSF) versus Herceptin + GM-CSF alone. The target study population is node-positive (NP) (or node-negative [NN] if negative for both ER and PR) breast cancer patients with HER2 1+ and 2+ expressing tumors who are disease-free after standard of care therapy. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA-typed. E75 is a CD8-eliciting peptide vaccine that was restricted to HLA-A2+ or HLA-A3+ patients (approximately two-thirds of the US population), and has been extended to HLA-A24+ and HLA-A26+ as well.
Eligibility: 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 have 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.

- Recovery from any toxicity(ies) associated with prior adjuvant therapy.

- HER2 expression of 1+ or 2+ by IHC. FISH or Dual-ISH testing must be performed on IHC 2+ tumors and shown to be non-amplified by FISH (≤2.0) or by Dual-ISH (≤2.0).

- HLA-A2, A3, A24, or A26 positive

- LVEF >50%, or an LVEF within the normal limits of the institution's specific testing (MUGA or Echo)

- 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)

- Must start study treatment (receive first Herceptin infusion) 15between 3-12 weeks from completion of standard of care therapy. 4.1.3 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 FISHDual-ISH amplified (FISH >2.0); Dual-ISH >2.0

- HLA-A2, A3, A24, A26 negative

- History of prior Herceptin therapy

- NYHA stage 3 or 4 cardiac disease

- LVEF <50%, or less than the normal limits of the institution's specific testing (MUGA or Echo)

- 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

- Any active autoimmune disease requiring treatment, with the exception of vitiligo

- Active pulmonary disease requiring medication to include multiple inhalers

- Involved in other experimental protocols (except with permission of the other study PI)
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