Vaccine Therapy in Treating Patients with Stage IB-IIIA Breast Cancer
- Participants who have been diagnosed with clinical or pathologic stage IB to stage IIIA adenocarcinoma of the breast (any subtype) who have undergone, and recovered from primary therapy (any combination of surgery, radiation, and/or chemotherapy and/or trastuzumab used to treat newly diagnosed disease), with their last dose/treatment (of any single or combination treatment) being between 45 days and 6 months (180 days) prior to enrollment; staging will be based on the Seventh Edition American Joint Committee on Cancer (AJCC) staging system; (systemic staging with computed tomography [CT] or positron emission tomography [PET] scans is not required by AJCC and is not required nor exclusionary for this trial)
- Participants may or may not be receiving hormonal therapy at the time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability and willingness to give informed consent
- Human leukocyte antigen (HLA)-A1, -A2, -A3, or -A31 positive
- Absolute neutrophil count (ANC) > 1000/mm^3
- Platelets > 100,000/mm^3
- Hemoglobin (Hgb) > 9 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limits of normal (ULN)
- Bilirubin =< 2.5 x ULN
- Alkaline phosphatase =< 2.5 x ULN
- Creatinine =< 1.5 x ULN
- Screening urinalysis < 5 white blood cell/high power field (WBC/hpf) (unless alternate urinary diagnosis not consistent with infection)
- Human immunodeficiency virus (HIV) and hepatitis c negative (serology)
- Gylcated hemoglobin (HgbA1c) < 7.5%
- Participants must have a minimum of two intact lymph node basins (any combination of axillary and inguinal basins that have not undergone complete nodal dissection)
- Participants with known or suspected allergies to any component of the vaccine
- Participants does not have a minimum of two intact lymph node basins (any combination of axillary and inguinal basins that have not undergone complete nodal dissection)
- Participants with an active infection requiring antibiotics are excluded (a positive screening urinalysis may be repeated)
- Participants receiving the following medications or treatments within the 6 weeks (42 days) prior to consenting; these medication and treatments may not be re-started at any time throughout the study in order to be remain eligible: * Breast tumor resection surgery (reconstructive surgery permitted) * Chemotherapy * Radiation therapy * Allergy desensitization injections * Growth factors (Procrit, Aranesp, Neulasta) * Other agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents) * Any investigational medication
- Participants that have been receiving the following medications or treatments within the 6 weeks (42 days) prior to consenting: * Corticosteroids, administered parenterally, orally, or inhaled (inhaled steroids, such as: Advair, Flovent, Azmacort) * Topical corticosteroids are acceptable
- Participants may not have been vaccinated previously with any of the synthetic peptides included in this protocol
- Participants with known active tuberculosis not on active antitubercular agents
- Pregnancy during vaccine administration; female participants of childbearing potential must have a negative pregnancy test (serum beta human chorionic gonadotropin [B-HCG]) prior to administration of the first vaccine dose
- Female participants of child bearing potential include any female who: * Has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) * Is not postmenopausal, defined as amenorrhea >= 12 consecutive months * Is on hormone replacement therapy with documented serum follicle stimulating hormone (FSH) level > 35 IU/mL
- Even women who are using oral, implanted, transdermal, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, practicing abstinence, or whose partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
- Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination
- Female participants must not be breastfeeding
- Participants in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator
- Participants classified according to the New York Heart Association classification as having class III or IV heart disease
- Participants that have experienced active autoimmune disorders requiring cytotoxic or immunosuppressive therapy within the 6 weeks (42 days) prior to consenting * The following will not be exclusionary: ** The presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody [ANA] titer) without symptoms ** Clinical evidence of vitiligo ** Other forms of depigmenting illness ** Mild arthritis requiring nonsteroidal antiinflammatory drug (NSAID) medications
I. To evaluate the safety of the vaccine + poly-ICLC (synthetic breast cancer peptides-tetanus toxoid-poly ICLC vaccine).
I. To estimate magnitude of cluster of differentiation (CD)8 T-cell activation following peptide + poly-ICLC vaccination.
II. To characterize the T-cell specificity of vaccine induced T-cells by the tetramer assay.
III. To describe the cytokine production of peripheral T-cells induced by vaccination + poly-ICLC.
IV. To describe the number of immune responses among patients treated with anti-estrogen therapies.
Patients receive synthetic breast cancer peptides-tetanus toxoid-poly ICLC vaccine intramuscularly (IM) and intradermally (ID) alternating arm and leg sites on days 1, 8, 15, 36, 57 and 78.
After completion of study treatment, patients are followed up annually for up to 3 years.
Trial Phase Phase II
Trial Type Treatment
University of Virginia Cancer Center
Patrick A. Dillon
- Primary ID Breast41
- Secondary IDs NCI-2014-02151, 1134
- Clinicaltrials.gov ID NCT01532960