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Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer

Phase 0
18 Years
Open (Enrolling)
Breast Cancer, Inflammatory Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Triple-negative Breast Cancer

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Trial Information

Pilot Study of a MUCI Peptide and Poly-ICLC Vaccine for Triple-Negative Breast Cancer


I. To evaluate the efficacy of MUC1 peptide-poly-ICLC adjuvant vaccine in boosting systemic
immunity to MUC1 in women who have completed therapy for AJCC(American Joint Committee on
Cancer)stage I-III 'triple-negative' [i.e., ER(-) PR(-) HER2/neu(-)] breast cancer.


I. To evaluate the safety and toxicity of the MUC1 peptide and poly-ICLC vaccine in this
cohort of patients.


Patients receive MUC-1 peptide vaccine subcutaneously (SC) and poly-ICLC vaccine SC in weeks
0, 2, and 10 in the absence of disease progression or unacceptable toxicity. Some patients
may receive a booster vaccine in week 52. Patients will be followed for study-related
Serious Adverse Events (SAEs) for a period of 30 days after their last vaccination. If a
patient experiences a SAE while participating in this study, they will be followed until the
resolution of the SAE.

Inclusion Criteria:

- AJCC stage I-III infiltrating adenocarcinoma of the breast who have completed
standard adjuvant or neoadjuvant therapy (surgery, radiation, biologic therapy,
chemotherapy) for TNBC (ER-, PR-, HER-2/neu-)

- Patients who have completed standard therapy for triple-negative inflammatory BC are

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Absolute neutrophil count >= 1,000/mm^3

- Hemoglobin >= 10.0 g/dl

- Platelet count >= 100,000/mm^3

- Total bilirubin must be within normal limits

- Transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase
[ALT]) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline
phosphatase is =< ULN

- Alkaline phosphatase may be up to 4 x ULN if transaminases are =< ULN

- Normal creatinine and blood urea nitrogen (BUN); if abnormal, calculated creatinine
clearance must be >= 60 mg/dL

- Human immunodeficiency virus (HIV)(-), antinuclear antibody (ANA)(-), hepatitis panel
(-), normal thyroid function tests; these tests will be performed at the discretion
of the Investigator if warranted by history or clinical presentation

- Patients must be disease-free of prior invasive malignancies for >= 5 years, with the
exception of curatively-treated basal cell or squamous cell carcinoma of the skin or
carcinoma in situ of the cervix

- All patients must have completed surgery with sentinel and/or axillary lymph node
dissection according to participating institutional guidelines

- All patients must have completed adjuvant radiation therapy according to
participating institutional guidelines

- All patients must have completed either adjuvant or neoadjuvant chemotherapy
according to participating institutional guidelines; the choice of chemotherapy is at
the discretion of the treating physician

- Women of childbearing potential must have a negative pregnancy test and must be
willing to consent to using an accepted and effective barrier form method of
contraception during participation in the study and for a reasonable period

- Patients must provide written informed consent

Exclusion Criteria:

- Known metastatic BC

- Radiotherapy, chemotherapy, biologic therapy, or other investigational therapy within
the preceding 4 weeks

- Previous splenectomy or radiotherapy to spleen

- Coexisting or previous malignancies except carcinoma in situ of the cervix or basal
cell carcinoma of the skin

- Active or uncontrolled infection

- Psychiatric, addictive, or any disorder that compromises the ability to give informed
consent to participate in or to comply with the requirements of the study

- Concurrent systemic corticosteroid treatment - must be off all steroids for at least
4 weeks prior to vaccine administration

- Any condition or behavior that in the judgment of the Investigator, would compromise
the patient's ability to participate in the study

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Proportion of patients showing a positive anti-MUC1 antibody response

Outcome Description:

Defined as a >= 2-fold enhancement from baseline anti-MUC1 antibody immunity, or for subjects with no antibody to MUC1 at baseline, any detectable antibody immunity against MUC1. To test the hypothesis of a sufficient immunologic response, we will apply a Simon's optimum 2-stage design. The proportion of patients with an immunologic response will be calculated with a 95% confidence interval using method developed for multistage clinical trials.

Outcome Time Frame:

At week 12 (2 weeks after the 3rd injection)

Safety Issue:


Principal Investigator

Joseph Baar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Inflammatory Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Triple-negative Breast Cancer
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms



Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065