Safety Study of Cancer Stem Cell Vaccinie to Treat Breast Cancer

To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the investigators will harvest peripheral blood and tumor specimen from patients with Breast Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the Breast Cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the Breast Cancer patient using a similar protocol as investigators reported .

Aim 1: To demonstrate, in vitro, the relative cellular anti-Breast Cancer CSC immunity induced by Breast Cancer CSC-DC primed cytotoxic T cells.

Aim 2: To determine, in vitro, specific binding and lysis of Breast Cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with Breast Cancer CSC-DC.

Inclusion criteria

• The patient is ≥ 30 years of age at the time the informed consent to screening has been obtained;
• The patient has one of the following histologically confirmed breast cancer subtypes:

Estrogen receptor and/or progesterone positive tumor; Human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer; HER2-negative breast cancer.

-- The patient shows normal organ function according to the following parameters(as measured within six weeks prior to treatment allocation):

• Hemoglobin: Within normal range according to institutional standards;
• Absolute leukocyte count: Within normal range according to institutional standards;
• Absolute lymphocyte count: Within normal range according to institutional standards;
• Platelet count: Within normal range according to institutional standards;
• Alanine aminotransferase: ≤ 2.5 x Upper Limit of Normal (ULN);
• Aspartate aminotransferase: ≤ 2.5 x ULN;
• Total bilirubin: ≤ 1.5 x ULN. In the case of known Gilbert's syndrome ≤ 2 x ULN;
• Serum creatinine: 1.5 x ULN;
• Calculated creatinine clearance: > 50 mL/min .

Exclusion criteria

• The patient has inflammatory breast cancer, which is defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion.
• Diagnosis established by incisional biopsy.
• Prior and concomitant neoadjuvant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers, endocrine therapy, and radiotherapy, unless authorized specifically by the protocol.
• level 3 hypertension;
• severe coronary disease;
• myelosuppression;
• respiratory disease;
• brain metastasis;
• chronic infections