Statement: Patients with permanent sensory loss, interfering with daily activities are excluded from the primary trial, but may still be eligible for the secondary trial.
Primary_evidence: Inclusion Criteria:   Written informed consent.   Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumors must be Human Epidermal Growth Factor Receptor 2 (HER2) negative. Patients must be free of disease in the axilla (node negative). If lymphadenectomy is done, at least 10 nodes must be examined. If sentinel node technique is used, sentinel node must be free of disease. Patients must present at least one high risk criterion (St. Gallen, 1998) as follows:   Tumor size > 2 cm; and/or   ER and Progesterone Receptor (PgR) negative; and/or   Histological grade 2-3; and/or   Age < 35 years old.   Time window between surgery and study randomization must be less than 60 days.   Surgery must consist of mastectomy or conservative surgery. Margins free of disease and ductal carcinoma in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.   Patients must not present evidence of metastatic disease.   Status of hormone receptors in primary tumor. Results must be available before the end of adjuvant chemotherapy.   Status of HER2 in primary tumor, known before randomization. Patients with Immunohistochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescent in situ hybridization (FISH) is mandatory and result must be negative.   Age >= 18 and <= 70 years old.   Performance status (Karnofsky index) >= 80.   Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).   Laboratory results (within 14 days prior to randomization):   Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100x 10^9/l; hemoglobin >= 10 mg/dl;   Hepatic function: total bilirubin <= 1 upper normal limit (UNL); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of AST and ALT > 1.5 UNL are associated with alkaline phosphatase > 2.5 UNL, patient is not eligible.   Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min.   Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week time window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests, as clinically indicated.   Patients able to comply with treatment and study follow-up.   Negative pregnancy test done in the 14 previous days to randomization. Exclusion Criteria:   Prior systemic therapy for breast cancer.   Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.   Prior radiotherapy for breast cancer.   Bilateral invasive breast cancer.   Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.   Any T4 or N1-3 or M1 tumor.   HER2 positive breast cancer (IHC 3+ or positive FISH result).   Pre-existing grade >=2 motor or sensorial neurotoxicity by the National Cancer Institute Common Toxicity Criteria (NCICTC) v-2.0.   Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.   History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.   Active uncontrolled infection.   Active peptic ulcer; unstable diabetes mellitus.   Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.   Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.   Concomitant treatment with other therapy for cancer. Males.
Secondary_evidence: DISEASE CHARACTERISTICS:   Histologically or cytologically confirmed adenocarcinoma of the breast   Stage III or IV disease   Primary or recurrent disease   Invasive lobular carcinoma allowed   HLA-A1, -A2, -A3, or -A31 positive   Underwent and recovered from prior primary therapy   Patients with no clinical or radiological evidence of disease who had a previous diagnosis of stage III or IV breast cancer must have undergone prior antineoplastic therapy including, but not limited to, surgery, chemotherapy, and radiotherapy within the past 36 months   Must have at least one undissected axillary and/or inguinal lymph node basin   No history of brain metastases   Hormone receptor status   Estrogen receptor-positive or -negative tumor   PATIENT CHARACTERISTICS:   ECOG performance status of 0 or 1   Body weight > 110 lbs (without clothes)   Male or female   Menopausal status not specified   Absolute neutrophil count > 1000/mm^3   Platelet count > 100,000/mm^3   Hemoglobin > 9 g/dL   Hemoglobin A1c < 7%   AST and ALT  2.5 x upper limit of normal (ULN)   Bilirubin  2.5 x ULN   Alkaline phosphatase  2.5 x ULN   Creatinine  1.5 x ULN   HIV negative   Hepatitis C negative   Not pregnant or nursing   Negative pregnancy test   Fertile patients must use effective contraception   No known or suspected allergies to any component of the vaccine   No active infection requiring antibiotics   No New York Heart Association class III or IV heart disease   No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement, except the following:   Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms   Clinical evidence of vitiligo   Other forms of depigmenting illness   Mild arthritis requiring nonsteroidal antiinflammatory drugs   No medical contraindication or potential problem that would preclude study participation   PRIOR CONCURRENT THERAPY:   More than 4 weeks since prior surgery   More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy   More than 4 weeks since prior and no concurrent allergy desensitization injections   More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids   No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide)   Prior or concurrent topical corticosteroids allowed   More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim)   More than 4 weeks since prior and no concurrent other investigational medication   More than 4 weeks since prior and no concurrent other agents with putative immunomodulating activity except for non-steroidal anti-inflammatory agents   Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene, fulvestrant, letrozole, anastrozole, or exemestane) allowed   No prior vaccination with any synthetic peptides in this protocol   Vaccines for infectious disease (e.g., influenza) allowed, provided they are administered  2 weeks prior to or  2 weeks after study vaccine   Short term therapy for acute conditions not related to breast cancer allowed   No concurrent illegal drugs